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For peer review only

Rehabilitation for balance dysfunction in patients after

stroke: a protocol of network meta-analysis

Journal: BMJ Open

Manuscript ID bmjopen-2018-026844

Article Type: Protocol

Date Submitted by the Author: 21-Sep-2018

Complete List of Authors: Li, Juan; CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE , School of Health Cultivation and Rehabilitation Zhong, Dongling; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and Rehabilitation Ye, Jing; Chengdu University of Traditional Chinese Medicine, Acu-moxibustion and Tuina school He, Mingxing; Chengdu University of Traditional Chinese Medicine Liu, Xicen; Chengdu University of Traditional Chinese Medicine

Zheng, Hui Jin, Rongjiang; Chengdu University of Traditional Chinese Medicine Zhang, Shao-lan; Chengdu Medical College, Immunology teaching and research section

Keywords: balance dysfunction after stroke, Modern rehabilitations, Traditional Chinese medicine therapies, network meta-analysis, protocol

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Rehabilitation for balance dysfunction in patients after stroke: a

protocol of network meta-analysis

Juan Li1†, Dongling Zhong

1†, Jing Ye

2†, Mingxing He

1, Xicen Liu

1, Hui Zheng

2, Rongjiang

Jin1*, Shaolan Zhang

3*

1. School of Health Cultivation and Rehabilitation, Cheng Du University of Traditional

Chinese Medicine, Si Chuan, China

2. School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Cheng Du

University of Traditional Chinese Medicine, Si Chuan, China

3. Chengdu Medical College, Si Chuan, China

†Juan Li, Dongling Zhong and Jing Ye contributed equally to this work.

Emails of authors: [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected];

*Corresponding authors: Professor Rongjiang Jin or Professor Shaolan Zhang, School of

Health Cultivation and Rehabilitation, Cheng Du University of Traditional Chinese

Medicine, Chengdu, 610075, China; Chengdu Medical College, Si Chuan, 610500, China.

E-mail: [email protected]; [email protected].

Abstract

Introduction

Multiple rehabilitation techniques have been reported to be effective for balance

dysfunction after stroke. However, the comparative effectiveness of these

rehabilitation techniques is still unclear. Therefore, the objective of this network

meta-analysis is to identify the most effective rehabilitation technique for balance

dysfunction after stroke.

Methods and analysis

The following databases will be searched: China Biology Medicine disc (CBM),

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China National Knowledge Internet (CNKI), Wan Fang Data, the Chinese Science

and Technology Periodical Database (VIP), Medline, EMBASE, Web of Science,

The Cochrane Library from inception to September 2018. All randomized controlled

trials (RCTs) utilized rehabilitations to treat the balance dysfunction in patients after

stroke will be included. The primary outcomes include the Berg balance scale (BBS),

the Fugl-Meyer Assessment (FMA) at the end of the treatment. The secondary

outcomes include the Barthel Index (BI), The Functional Ambulation Category Scale

(FAC), Fall rates, The Timed Up-and-go Test (TUGT), The MOS 36-item short-form

health survey (SF-36), and adverse events. In order to ensure that all relevant studies

will be included without personal biases, study selection, data extraction and quality

assessment will be performed independently by two reviewers. Assessment of risk of

bias will be performed using Review Manager V5.3 software and data synthesis will

be performed using WinBUGS 1.4.3 and R software.

Discussion

The findings of this network meta-analysis will summarize the direct and indirect

evidence of rehabilitations on balance dysfunction after stroke, it may also provide a

ranking of rehabilitation techniques for patients and therapists to choose the best

option.

Ethics and dissemination

The ethics approval is not required in network meta-analysis and the results will be

submitted to a peer review journal.

Trial registration number: PROSPERO (CRD 42018107441)

Strength and limitations of this study

� This study will be the first network meta-analysis to compare the effectiveness

and safety of different rehabilitation techniques for balance dysfunction after

stroke.

� The results of this study will provide evidence for the management of balance

dysfunction and help the therapists and patients to make decision.

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� In order to ensure that all relevant studies are included without personal biases,

study selection, data extraction and quality assessment will be performed

independently by two reviewers.

� Although the electronic search and hand search will be performed in this study,

potential unpublished trials are inevitable, which might introduce some bias. To

overcome this limitation, the experts in this field will be consulted for

unpublished trials.

� Owing to the difficulty of locating all the effective rehabilitation techniques for

balance dysfunction after stroke, we will review the guideline and consult the

experts for the recommended rehabilitation techniques.

Introduction

Stroke is a common clinical cerebrovascular disease, with a high morbidity, mortality,

and disability rates, which brings a heavy economic burden to society and families.

About 75% of patients after stroke have various degrees of impairment in the motor

system, sensory system, and activities of daily living (ADL)1. Stroke often leads to

reduction in muscle strength, muscle spasms, prosthetic sensory disorder, visual and

other impairments which affect the balance function of the patients. The completion

of most daily tasks depends on the normal balance function of the body, such as

standing, walking, and bathing. Balance dysfunction is one of the common daily

functional problems in stroke patients, which seriously affects the patient's daily life

and work. Patients after stroke have impaired standing and control of trunk posture,

which affects balance function2and daily lives, even worse, increases the risk of

falls3 4. In stroke patients, an increase in the risk of falls means lower quality of life

5.

Balance function is the ability to maintain the center of gravity within the limits of

base of support as in sitting, standing, walking or position transfering6. The control

of human balance is a comprehensive process relying on the integration of visual,

vestibular and somatosensory inputs in the central nerve system. One of the most

common problems encountered in patients with stroke is loss of balance which can

result in falls and serious injuries7. Falling is one of the most common complications

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in stroke rehabilitation process and can cause physical, psychological and

pathological changes8. It is likely to lead to recurrence of stroke and life-threatening

events9. Falls are more frequent in patients with stroke during hospitalization or

community rehabilitation. In the acute treatment period, there were 14% to 64.5% of

the elderly who had fallen, 24% to 47% in the rehabilitation phase, and 37.5% to 73%

of the cerebrovascular patients who returned to the community. Over 47% of elderly

patients with stroke in the community have fallen more than once10. Falling leads to

lengthen the hospital stay for the elderly, increase medical and nursing costs, and

cause economic losses directly or indirectly. The reports showed that China's annual

medical expenses caused by falls exceed 5 billion yuan, resulting in a direct or

indirect social cost of approximately 160 to 80 billion yuan11. Management of

balance dysfunction in patients with stroke plays a key role in fall prevention.

Numerous rehabilitation techniques have been used to treat balance dysfunction after

stroke, mainly caused by proprioception, visual impairment, vestibular dysfunction,

decreased central nervous system integration, decreased core muscle strength,

decreased muscle synergy, and cognitive dysfunction12. Modern rehabilitations like

proprioceptive neuromuscular facilitation (PNF)13 14, balance training instrument

(such as balance ball or balance board)15 16, visual feedback instrument

17, vestibular

rehabilitation therapy (VRT)18 19, neuromuscular training

20 and so on. Traditional

Chinese medicine therapies, including acupuncture, moxibustion, Chinese medicine,

Tuina, traditional Chinese exercises (TCEs)21 and so on. Rehabilitation techniques

for balance dysfunction after stoke mostly concentrate on increasing core muscle

strength and changing the center of gravity. TCEs like Tai Chi contains many

exercises of balance control, such as the weight of the body moved from one side to

the other, and between the single foot and the two feet22. Modern rehabilitations

usually increase balance dysfunction by creating an unbalanced plane, whether the

plane is virtual (using virtual reality technology) or realistic (using balance ball or

balance board).

With the development of evidence-based medicine, numerous systematic reviews

(SRs) have been conducted to investigate the effectiveness and safety of multiple

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rehabilitation techniques for balance dysfunction after stroke23-26. However, the

comparative effectiveness of these rehabilitation techniques is still unclear.

Unlike traditional pairwise meta-analysis, network meta-analysis is capable to

summarize the direct and indirect evidence and evaluate the relative efficacy of

multiple treatment comparisons. What is more, network meta-analysis is able to

provide the ranking of treatment options based on their effectiveness, which is

helpful for the doctors and patients to make the best choice of treatment.

Therefore, the purpose of this study is to compare different rehabilitation techniques

to determine their relative effectiveness and safety in the treatment of balance

dysfunction after stroke. We also aim to identify the most effective rehabilitation

technique for balance dysfunction after stroke.

2 Methods

2.1 Registration

The protocol of this network meta-analysis has been registered with the international

prospective register of systematic reviews (PROSPERO,

http://www.crd.york.ac.uk/PROSPERO). The registration number of this network

meta-analysis is CRD 42018107441. The protocol will be reported in accordance

with the guidelines of the Preferred Reporting Item for Systematic Review and

Meta-analysis Protocols (PRISMA-P).

2.2 Inclusion criteria

Type of studies

Only randomized controlled trials (RCTs) will be included. Trials without control

group or those with quasi-random allocation will be excluded. There are no

restrictions on language or publication date.

Type of participants

We will include RCTs that involved post-stoke patients which diagnosed according

to the stroke diagnostic criteria formulated by The Fourth National Cerebrovascular

Disease Conference in 199527, A Guide to the Prevention and Treatment of Chinese

Cerebrovascular Disease developed by the Chinese Medical Association in 200528,

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Standard for the Diagnosis and Evaluation of Stroke Difficulties formulated by the

Encephalopathy Emergency Team of the State Administration of Traditional Chinese

Medicine in 199629. There is no restriction on age, sex and race.

Type of interventions

Studies that used modern rehabilitation (such as proprioceptive neuromuscular

facilitation (PNF), balance training instrument (such as balance ball or balance

board), visual feedback instrument, vestibular rehabilitation therapy (VRT),

neuromuscular training ect.) or traditional Chinese medicine therapies (including

acupuncture, moxibustion, Chinese medicine, tuina, traditional Chinese exercise

(TCE) etc.) to treat patients with balance dysfunction after stoke.

Outcome measurements

In this network meta-analysis, all the following outcomes after the end of

interventions and after a follow-up time will be included.

Primary outcomes

The primary outcomes are the Berg balance scale (BBS) and the Fugl-Meyer

Assessment (FMA).

BBS assesses the functional postural abilities of patients in several conditions (lying

on the back, sitting, standing, leaning forward, change of position and so on). This

scale is composed of 14 items. The maximal score, reflecting the best functional

postural abilities, is 56 points30-32.

FMA as a method for assessing the balance was developed from the Brunnstrom

Level 6 functional grading (BRSS). This scale is composed of 7 items with 3 levels.

The maximal score is 14 points. Lower score, means more severe balance

dysfunction33.

Secondary outcomes

The secondary outcomes are the Barthel Index (BI), The Functional Ambulation

Category Scale (FAC), Fall rates, The Timed Up-and-go Test (TUGT), The MOS

36-item short-form health survey (SF-36), adverse events during the entire treatment

and follow-up period.

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BI, FAC, TUGT are outcomes for motor function; BI, SF-36 are outcomes for the

quality of life; Fall rates, adverse events during the entire treatment and follow-up

period are outcomes for the safety.

BI is used as standard measures for ADL and motor function34. FAC is an

assessment tool designed to categorize functional ambulation ability. TUGT is a

simple test used to assess a person's mobility and requires both static and dynamic

balance35.

2.3 Exclusion criteria

The following will be excluded: ①non-RCTs, cluster randomized trials, array

studies, reviews, case-control studies. ②balance dysfunction was not caused by

stroke, for example, caused by Parkinson’s disease, Pediatric cerebral palsy, knee

surgery or other diseases. ③duplicate or the data cannot be extracted. ④full text

cannot be obtained through various approaches.

2.4 Database and search

The following databases will be searched from inception to September 2018: China

Biology Medicine disc (CBM), China National Knowledge Internet (CNKI), Wan

Fang Data, the Chinese Science and Technology Periodical Database (VIP), Medline,

EMBASE, Web of Science, The Cochrane Library. And we will also search RCT

registration website, including http://www.ClinicalTrial.gov and

http://www.chictr.org.cn. A professional medical librarian (HZ) will design and

revise the search strategy. Relevant magazines and websites will be searched to

avoid missing eligible trials. Reference lists of identified publications will also be

manually searched. Experts in this field will be consulted for unpublished trials.

Search strategy please see appendixⅠ.

2.5 Studies selection

All the retrieved studies will be imported into Endnote(X8) and filtered the

duplicated studies. Two reviewers (DLZ and MXH) will screen the titles and

abstracts independently according to the inclusion and exclusion criteria then cross

check. Two reviewers (DLZ and MXH) will download the full text of all possibly

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relevant studies for further assessment independently then cross check. In case of

disagreements, two reviewers (DLZ and MXH) will resolve through team discussion

or a third reviewer (RJJ) will be involved.

2.6 Data extraction

A standardized data extraction form will be designed in advance. After identify all

the included studies, two reviewers (DLZ and MXH) will independently extract data,

which including study characteristics (author and published year), participant

characteristics (simple size, age, sex, disease course etc.), interventions (duration,

frequency, study period etc.), comparisons(duration, frequency, study period etc.),

outcomes (BBS, FMA, BI or SF-36) then the two reviewers (DLZ and MXH) will

cross check to make sure there is no misentry. In case of disagreements, two

reviewers (DLZ and MXH) will resolve through discussion or a third reviewer (SLZ)

will be involved.

2.8 Risk of bias assessment

The Cochrane risk of bias tool(www.cochrane-handbook.org.)36 will be used to

assess the risk of bias including the following items: random sequence generation,

allocation concealment, blind subjects, blind therapists and assessors, incomplete

outcome data, selective outcome reporting and other bias. If the study meets all

criteria will be categorized as low risk of bias; the trials with insufficient information

to judge will be categorized as unclear risk of bias; the trials meet none of the criteria

will be categorized as high risk of bias. Two reviewers (XCL and JL) will assess the

risk of bias independently then cross check to make sure no mistake. In case of

disagreements, two reviewers (XCL and JL) will resolve through discussion or a

third reviewer (RJJ) will be involved. Review Manager V5.3 software will be used to

make bias risk diagram.

2.9 Grading the quality of evidence

To help health professional make decisions regarding individual patients, we will

evaluate the quality of evidence for outcomes by using the

Grades of Recommendations, Assessment, Development and Evaluation (GRADE)

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system (http://www.gradeworkinggroup.org/society/index.htm). The GRADE includes

the following five aspects: limitations in study design, inconsistency, indirectness,

imprecision, and publication bias37. The quality of evidence will be graded as ‘high’,

‘moderate’, ‘low’ or ‘very low’ in accordance with the GRADE rating standards38.

The results of GRADE including evidence profile (EP) and summary of finding table

(SoF) will be generated using GRADE pro software.

2.10 Statistical analysis

Network meta-analysis

All the data for statistical analysis will be extracted in an excel file. The network

analysis will be used in the Bayesian framework using the Markov Chain Monte

Carlo (MCMC) algorithm. The node splitting will be performed to check

inconsistency when compare the indirect evidence with direct evidence. We will

adopt the deviance information criterion (DIC) to explore the model fitness, in which

the fixed and random effects model will be compared.

Since both primary outcomes and secondary outcomes are continuous data, the effect

size of the rehabilitation techniques will be calculated with the standardized mean

difference (SMD). If the trial present mean values of each time point, we will adjust

the outcomes by the baseline values. We will calculate the SMD directly for the trials

present the values of outcomes changing from baseline. The 95% credible interval

(CrI) of each SMD will also be calculated.

For each outcome, the rankogram plots and the surface under the cumulative ranking

curves (SUCRA) will be used to estimate the hierarchy of the different rehabilitation

techniques. A rankogram plots show the probabilities for rehabilitation techniques to

assume any of the possible rank. SUCRAs will be present as percentage. 100% for

the best treatment while 0% for the worst. Data analysis will be performed using

WinBUGS 1.4.3 and R software.

We will perform a narrative review and summarize the evidences, if the available

data are not suitable for synthesis.

Dealing with missing data

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If the extracted data is missing, the original authors will be contacted for more

information. If there are no reply from the original authors, we will try to calculate

the data through the available coefficients, the potential impact of these missing data

on the results of the systematic review will be examed in the sensitivity analysis.

Subgroup analysis

If significant heterogeneity between studies is found, we will search for the possible

causes from both clinical and methodological perspectives and provide an

explanation. Subgroup analysis and meta regression will be performed to explore

heterogeneity if sufficient comparable studies(≥ 10) are identified. Subgroup

analysis and meta regression will be performed based on age, sex, type of stroke,

disease course of stroke, the severity of balance dysfunction, the duration of

treatment. Also, the network meta regression will be conducted to explore the

possible sources of heterogeneity.

Sensitivity analysis

Sensitivity analysis of primary outcomes will be carried out to verify the robustness

of the study conclusions, assessing the impact of methodological quality, study

design, sample size and the effect of missing data as well as the analysis methods on

the result of this review.

Assessment of publication bias

For publication bias, each included study will be assessed according to the

CONSORT criterial; If the included studies is sufficient (≥10), funnel plot will be

generated to explore the potential for publication bias. If funnel plots are asymmetric,

we will try to interpret funnel plot asymmetry39.

3 Discussion

Balance dysfunction is one of the common daily functional problems in stroke

patients, which seriously affects the patient's daily life and work. Moreover, balance

dysfunction often leads to high fall rates, which brings great burden to stroke

patients, families and society. In addition, good balance function is the prerequisite

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for recovering the ability of independent walking.

Currently, multiple rehabilitation techniques have been reported to be effective for

balance dysfunction after stroke, such as acupuncture therapy40, robot-assisted

lower-limb rehabilitation41 and so on. Recent systematic reviews

42-44indicated that

modern rehabilitations and TCEs have beneficial effects on the balance function

among stroke patients. However, among the multiple rehabilitation techniques, the

comparative effectiveness of these rehabilitation techniques is still unclear.

Network meta-analysis is capable to summarize the direct and indirect evidence and

evaluate the relative efficacy of multiple treatment comparisons45. What is more,

network meta-analysis is able to provide the ranking of treatment options based on

their effectiveness.

Therefore, we will conduct this network meta-analysis aiming at assessing which

rehabilitation technique is the most effectiveness when compared with others. To this

purpose, this network systematic review aims at upgrading and improving the

rehabilitation of balance dysfunction by a complete analysis of all rehabilitation

techniques.

This is the first network meta-analysis to summarize the direct and indirect evidence

and compare the effects of different rehabilitation techniques in the management of

balance dysfunction after stroke. We hope that the finding of our study will provide

clinical recommendation for both therapists and patients with balance dysfunction

after stroke.


The ethics approval is not required in network meta-analysis. The results will be

reported in accordance with PRISMA. The findings will be submitted to peer review

journal or conference.

Contributors: RJJ and SLZ designed this systematic review. JL, DLZ and JY

draft the manuscript. The search strategy was developed by HZ. All authors

approved the publication of this protocol.

Funding: This work was financially funded by the National Natural Science

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Foundation of China (grant numbers 81674047 and 81704137).

Competing interests: None declared.

Data sharing statement: Not applicable.

Provenance and peer review: Not commissioned; externally peer reviewed.

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328( 7454) : 1490.

38. Zeng Xiantao LW, Li Sheng, et al. How to understand and use the GRADE system

correctly. Chinese Journal of Evidence-based Medicine 2011, 11(9):985-990.

39. Sterne JA SA, Ioannidis JP, et al. Recommendations for examining and interpreting

funnel plot asymmetry in meta-analyses of randomized controlled trials. BMJ 2011

Jul 22;343:d4002.

40. H. Zheng WLL, H. ShangGuan, et al. Effect of acupuncture and moxibustion treatment on

limb motor dysfunction among stroke patients: meta-analysis. Chin J Rehabilitation

Med:31 (2) (2016) 217e221.

41. H. Li JMF, X.D. Gu, et al. The effects of robot-assisted lower-limb rehabilitation plus

psychological intervention on post-stroke depression. Chin J Phys Med

Rehabilitation:35 (8) (2013) 630e633.

42. B.L. Chen JBG, M.S. Liu, et al. Effect of traditional Chinese exercise on gait and balance

for stroke: a systematic review and meta-analysis. Plos One 10 (8)(2015) e0135932.

43. Ge L ZQX, Liao Y T, et al. Effects of traditional Chinese exercises on the rehabilitation of

limb function among stroke patients: A systematic review and meta-analysis.

Complementary Therapies in Clinical Practice:2017, 29:35.

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44. Li Z HX, Sheng J, et al. Virtual reality for improving balance in patients after stroke: A

systematic review and meta-analysis. Clinical Rehabilitation:2016, 30(5).

45. Lumley T. Network meta-analysis for indirect treatment comparisons. Statistics in

Medicine 2010;21(16):2313-24.

Figure 1 flowchart of network meta-analysis of rehabilitation for the balance dysfunction in

patients with stroke (Abbreviation: CBM: China Biology Medicine disc, CNKI: China National

Knowledge Internet, VIP: the Chinese Science and Technology Periodical Database)

Appendix N. Web of science search strategy.

number Search terms

1 Randomized controlled trial

2 Controlled clinical trial

3 Randomly

4 Randomized

5 Randomized

6 Trial

7 Or/1–6

8 Balance dysfunction after stroke

9 acupuncture

electroacupuncture

fire needle

body acupuncture

warm needle

auricular acupuncture

10 Tuina

Chinese tuina

Massage

Massage therapy

Chinese massage

Chinese manipulation

Chinese manipulative therapy

Chinese manipulation

11 Moxibustion

12 Chinese medicine

13 traditional Chinese exercises

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14 Proprioceptive neuromuscular facilitation

PNF

15 balance training instrument

balance ball

balance board

16 visual feedback instrument

17 vestibular rehabilitation therapy

VRT

18 neuromuscular training

19 Or/9–18

20 7 AND 8 AND 19

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flowchart of network meta-analysis of rehabilitation for the balance dysfunction in patients with stroke

210x297mm (200 x 200 DPI)

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Reporting checklist for protocol of a systematic review.

Based on the PRISMA-P guidelines.

Instructions to authors

Complete this checklist by entering the page numbers from your manuscript where readers will find

each of the items listed below.

Your article may not currently address all the items on the checklist. Please modify your text to

include the missing information. If you are certain that an item does not apply, please write "n/a" and

provide a short explanation.

Upload your completed checklist as an extra file when you submit to a journal.

In your methods section, say that you used the PRISMA-P reporting guidelines, and cite them as:

Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA. Preferred

Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement.

Syst Rev. 2015;4(1):1.

Reporting Item

Page

Number

Identification #1a Identify the report as a protocol of a systematic review 1

Update #1b If the protocol is for an update of a previous systematic

review, identify as such

-

#2 If registered, provide the name of the registry (such as

PROSPERO) and registration number

5

Contact #3a Provide name, institutional affiliation, e-mail address of all

protocol authors; provide physical mailing address of

corresponding author

1

Contribution #3b Describe contributions of protocol authors and identify the

guarantor of the review

1

#4 If the protocol represents an amendment of a previously

completed or published protocol, identify as such and list

changes; otherwise, state plan for documenting important

-

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protocol amendments

Sources #5a Indicate sources of financial or other support for the review 11

Sponsor #5b Provide name for the review funder and / or sponsor 11

Role of sponsor or

funder

#5c Describe roles of funder(s), sponsor(s), and / or institution(s),

if any, in developing the protocol

-

Rationale #6 Describe the rationale for the review in the context of what is

already known

3-5

Objectives #7 Provide an explicit statement of the question(s) the review will

address with reference to participants, interventions,

comparators, and outcomes (PICO)

5

Eligibility criteria #8 Specify the study characteristics (such as PICO, study design,

setting, time frame) and report characteristics (such as years

considered, language, publication status) to be used as

criteria for eligibility for the review

5-7

Information

sources

#9 Describe all intended information sources (such as electronic

databases, contact with study authors, trial registers or other

grey literature sources) with planned dates of coverage

7

Search strategy #10 Present draft of search strategy to be used for at least one

electronic database, including planned limits, such that it

could be repeated

15

Study records -

data management

#11a Describe the mechanism(s) that will be used to manage

records and data throughout the review

7-8

Study records -

selection process

#11b State the process that will be used for selecting studies (such

as two independent reviewers) through each phase of the

review (that is, screening, eligibility and inclusion in meta-

analysis)

7

Study records -

data collection

process

#11c Describe planned method of extracting data from reports

(such as piloting forms, done independently, in duplicate), any

processes for obtaining and confirming data from investigators

8

Data items #12 List and define all variables for which data will be sought

(such as PICO items, funding sources), any pre-planned data

assumptions and simplifications

8

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Outcomes and

prioritization

#13 List and define all outcomes for which data will be sought,

including prioritization of main and additional outcomes, with

rationale

6

Risk of bias in

individual studies

#14 Describe anticipated methods for assessing risk of bias of

individual studies, including whether this will be done at the

outcome or study level, or both; state how this information will

be used in data synthesis

8

Data synthesis #15a Describe criteria under which study data will be quantitatively

synthesised

9

#15b If data are appropriate for quantitative synthesis, describe

planned summary measures, methods of handling data and

methods of combining data from studies, including any

planned exploration of consistency (such as I2, Kendall’s τ)

9

#15c Describe any proposed additional analyses (such as

sensitivity or subgroup analyses, meta-regression)

10

#15d If quantitative synthesis is not appropriate, describe the type

of summary planned

10

Meta-bias(es) #16 Specify any planned assessment of meta-bias(es) (such as

publication bias across studies, selective reporting within

studies)

10

Confidence in

cumulative

evidence

#17 Describe how the strength of the body of evidence will be

assessed (such as GRADE)

-

The PRISMA-P checklist is distributed under the terms of the Creative Commons Attribution License

CC-BY 4.0. This checklist can be completed online using https://www.goodreports.org/, a tool made

by the EQUATOR Network in collaboration with Penelope.ai

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For peer review onlyRehabilitation for balance impairment in patients after

stroke: a protocol of a systematic review and network meta-analysis

Journal: BMJ Open

Manuscript ID bmjopen-2018-026844.R1


Date Submitted by the Author: 13-Feb-2019

Complete List of Authors: Li, Juan; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhong, Dongling; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationYe, Jing; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalHe, Mingxing; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationLiu, Xicen; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZheng, Hui ; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalJin, Rongjiang; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhang, Shao-lan; Chengdu Medical College, Immunology teaching and research section

<b>Primary Subject Heading</b>: Evidence based practice

Secondary Subject Heading: Rehabilitation medicine, Evidence based practice, Complementary medicine

Keywords:Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Rehabilitation medicine < INTERNAL MEDICINE, STROKE MEDICINE, THERAPEUTICS, COMPLEMENTARY MEDICINE


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Rehabilitation for balance impairment in patients after stroke: a

protocol of a systematic review and network meta-analysis

Juan Li1†, Dongling Zhong1†, Jing Ye2†, Mingxing He1, Xicen Liu1, Hui Zheng2, Rongjiang

Jin1*, Shaolan Zhang3*

1. School of Health Cultivation and Rehabilitation, Chengdu University of Traditional

Chinese Medicine, Chengdu, Sichuan, China

2. School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Chengdu

University of Traditional Chinese Medicine, Chengdu, Sichuan, China

3. Chengdu Medical College, Chengdu, Sichuan, China





Health Cultivation and Rehabilitation, Chengdu University of Traditional Chinese

Medicine, Chengdu, Sichuan, 610075, China; Chengdu Medical College, Chengdu, Sichuan,

610500, China.


Abstract

Introduction

Multiple rehabilitation therapies have been reported effective for post-stroke balance

impairment. However, the comparative effectiveness of these rehabilitation therapies is

still unclear. Therefore, the aim of this study is to summarize evidence and identify the

most effective rehabilitation therapy for post-stroke balance impairment.


The following databases will be searched: China Biology Medicine disc (CBM), China

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National Knowledge Internet (CNKI), Wan Fang Data, the Chinese Science and

Technology Periodical Database (VIP), Medline, EMBASE, Web of Science, The

Cochrane Library from inception to September 2018. All randomized controlled trials

(RCTs) that have utilized rehabilitation interventions to treat post-stroke balance

impairment will be included. The primary outcomes are the Berg Balance Scale (BBS),

the Fugl-Meyer Assessment (FMA (balance)), the Postural Assessment Scale for Stroke

(PASS), as well as the Function In Sitting Test (FIST), the Sitting Balance Scale (SBS),

the Ottawa Sitting Scale, the Activities-specific Balance Confidence scale (ABC), the

Overall Balance Index (OBI) and the Brunel Balance Assessment (BBA). The

secondary outcomes include the Barthel Index (BI), The Functional Ambulation

Category Scale (FAC), fall rates, the Timed Up-and-go test (TUG), the MOS 36-item

short-form health survey (SF-36), and adverse events. To ensure that all relevant studies

will be included without personal bias, study selection, data extraction and quality

assessment will be performed independently by two reviewers. Risk of bias will be

assessed with the Cochrane risk of bias assessment tool. Review Manager V5.3

software will be used to make bias risk diagram and pairwise meta-analysis, while

network data synthesis will be performed using WinBUGS 1.4.3 and R software.


Ethics approval is not required in systematic review and network meta-analysis. The

results will be submitted to a peer review journal.


Strengths and limitations of this study

This study will be the first network meta-analysis to compare the effectiveness and

safety of different rehabilitation physiotherapists for post-stroke balance

impairment.

The results of this study will provide evidence for the management of balance

impairment and help the therapists and patients to choose suitable treatment.

In order to ensure that all relevant studies will be included without personal bias,

study selection, data extraction and quality assessment will be performed

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independently by two reviewers.

Although both electronic search and hand search will be performed in this study,

potential unpublished trials are inevitable. To overcome this limitation, the experts

in this field will be consulted for unpublished trials.

Owing to the difficulty of locating all the effective rehabilitation therapies for post-

stroke balance impairment, we will review the guideline and consult the experts for

the recommended rehabilitation therapies.

1 Introduction

Stroke is a common clinical cerebrovascular disease, with high morbidity, mortality,

and disability rates, which brings a heavy economic burden to society and families1-3.

It is reported that about 83% of stroke survivors suffered from balance impairment.

Balance impairment is characterized by short supporting time and differences between

two sides of the body and slow walking speed, which may increase the risk of falls4 and

restrict participation in activities5. Fear of falling can contribute to sedentary lifestyle

and increased disability, which means lower quality of life6.

Falling often leads to longer hospital stay, more medical and nursing costs, and

economic losses directly or indirectly. It is reported that in China, annual medical

expenses caused by cerebrovascular falls exceed 5 billion yuan, resulting in a direct or

indirect social cost of approximately 160 to 80 billion yuan7. Therefore, management

of balance impairment is challenging for patients with stroke.

Balance is the ability to maintain the line of gravity within the base of support with

minimal postural sway8. The control of human balance is a comprehensive process

relying on the integration of visual, vestibular and somatosensory inputs in the central

nervous system. Numerous rehabilitation therapies have been used to improve balance

ability of stroke patients including whole body vibration (WBV)9, virtual reality (VR)10

11, exercise12, mirror therapy (MT)13-15, traditional Chinese medicine (TCM)16,

traditional Chinese exercise (TCE)17-20, ankle-foot orthosis (AFO)21 and so on.

It is reported that WBV is able to improve results of the Functional Reach Test and the

Timed Up-and-go test (TUG), which has a positive effect on the balance and gait

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function of stroke patients22. Results of one RCT concluded that VR is an effective

rehabilitation therapy which can improve postural balance and upper extremity function

in post-stroke patients23. Exercises such as bilateral upper extremity exercises24, step

climbing exercise25 and trampoline training26 are beneficial for balance ability and fall

prevention. Recent systematic reviews and meta-analyses showed that MT can improve

balance, mobility, gait speed, and motor function compared to control groups13-15. AFO

is capable to improve the gait and balance in patient with balance impairment after

stroke27. Acupuncture is an important part of TCM, which has been used to restore limb

movement and balance disability in patients with stroke16. Results from several meta-

analysis showed that TCE including Tai Chi, Baduanjin, Yijinjing, Liuzijue and so on

can effectively enhance the balance ability by increasing the Berg Balance Scale score

and reducing fall rate19.

Based on these grounds, we raise an important clinical question: among these

rehabilitation therapies, which is the most comparative effective and safe therapy to

enhance balance ability for post-stroke patients.

Different from traditional pairwise meta-analysis, network meta-analysis (NMA) is

capable to summarize the direct and indirect evidence and evaluate the relative efficacy

of multiple treatment comparisons. What is more, NMA is able to provide the ranking

of treatment options based on their effectiveness. Therefore, to help physiotherapists

and patients make better choice in improving balance, a systematic review and NMA

will be conducted to summarize the evidence of various rehabilitation therapies and to

identify the most effective rehabilitation therapy for post-stroke balance impairment.

2 Methods

2.1 Registration

The protocol of this NMA has been registered with the international prospective register

of systematic reviews (PROSPERO, http://www.crd.york.ac.uk/PROSPERO). The

registration number of this NMA is CRD 42018107441. The protocol will be reported

in accordance with the guidelines of the Preferred Reporting Item for Systematic

Review and Meta-analysis Protocols (PRISMA-P). The procedure of this review is

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5

shown in figure 1.


Type of studies

Only randomized controlled trials (RCTs) will be included. Trials without control group

or those with quasi-random allocation will be excluded. There will be no restrictions on

language or publication date.

Types of participants

We will include RCTs that involved post-stoke patients diagnosed according to the

stroke diagnostic criteria formulated by The Fourth National Cerebrovascular Disease

Conference in 199528, A Guide to the Prevention and Treatment of Chinese




Medicine in 199630. There will be no restriction on age, sex and race.

Types of interventions

Experts were consulted for the recommended rehabilitation therapies. All kinds of

rehabilitation therapies for post-stroke balance impairment including traditional

Chinese medicine therapies (such as acupuncture moxibustion, Tai Chi and so on) and

modern rehabilitation therapies (which refer to physical therapies defined by the World

Confederation for Physical Therapy (WCPT) (http://www.wcpt.org/policy/ps-

descriptionPT)), typically including balance-specific activities (such as balance

exercises, weight shift training and so on), more general activities (such as

strengthening exercises, gait activities and so on), biofeedback, WBV, VR, MT,

orthosis and so on.


Primary outcomes will focus on balance ability. Secondary outcomes will include

functional ambulatory ability as well as quality of life.

Primary outcomes

The primary outcomes include the Berg Balance Scale (BBS), the Postural Assessment

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Scale for Stroke (PASS) and the Fugl-Meyer Assessment (FMA(balance))31, as well as

the Function In Sitting Test (FIST), the Sitting Balance Scale (SBS), the Ottawa Sitting

Scale, the Activities-specific Balance Confidence (ABC) scale, the Overall Balance

Index (OBI) and the Brunel Balance Assessment (BBA).

BBS assesses the functional postural abilities of patients in several conditions (lying on

the back, sitting, standing, leaning forward, change of position and so on). This scale is

composed of 14 items. The maximal score, reflecting the best functional postural

abilities, is 56 points32-34.

FMA (balance) as a method for assessing the balance was developed from the

Brunnstrom Level 6 functional grading. This scale is composed of 7 items with 3 levels. The maximal score is 14 points. Lower score means more severe balance impairment35.

PASS was developed specifically for assessing balance in stroke patients. PASS

demonstrates high reliability36, favorable individual item agreement37, and high test-

retest reliability38 39.

Secondary outcomes

The secondary outcomes will include the Barthel Index (BI), The Functional

Ambulation Category Scale (FAC), fall rates, TUG, The MOS 36-item short-form

health survey (SF-36), adverse events.

BI is used as standard measures for activities of daily living and motor function40. FAC

is an assessment tool designed to categorize functional ambulation ability. TUG is a

simple test used to assess a person's mobility and requires both static and dynamic

balance41.


The following will be excluded: ①non-RCTs, cluster randomized trials, cross-over

designs, cohort studies, reviews, case-control studies. ② balance impairment not

caused by stroke, for example, caused by Parkinson’s disease, Pediatric cerebral palsy,

knee surgery or other diseases. ③duplicate or un-extracted data. ④full text can’t be

obtained through various approaches.

2.4 Data sources and search

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https://en.wikipedia.org/wiki/Balance_(ability)



7

The following databases will be searched from inception to September 2018: China

Biology Medicine disc (CBM), China National Knowledge Internet (CNKI), Wan Fang

Data, the Chinese Science and Technology Periodical Database (VIP), Medline,

EMBASE, Web of Science, The Cochrane Library. And we will also search RCT

registration website, including http://www.ClinicalTrial.gov and

http://www.chictr.org.cn. A professional medical librarian (HZ) will design and revise

the search strategy. Relevant magazines and websites will be searched to avoid missing

eligible trials. References list of identified publications will also be manually searched.

Experts in this field will be consulted for unpublished trials. Search strategy please see

AppendixⅠ.


All the retrieved studies will be imported into Endnote(X8) and the duplicated studies

will be deleted. Two reviewers (DLZ and MXH) will screen the titles and abstracts

independently according to the inclusion and exclusion criteria then cross check. Two

reviewers (DLZ and MXH) will download the full texts of all possibly relevant studies

for further assessment independently then cross check. In case of disagreements, two

reviewers (DLZ and MXH) will resolve through team discussion or a third reviewer

(RJJ) will be involved.

2.6 Data extraction

A standardized data extraction form will be designed in advance. After identifying all

the included studies, two reviewers (DLZ and MXH) will independently extract data,

including study characteristics (author and published year), participant characteristics

(simple size, age, sex, disease course and so on), interventions (duration, frequency,

study period and so on), comparisons (duration, frequency, study period and so on),

outcomes (BBS, FMA (balance), BI, SF-36 and so on). Then two reviewers (DLZ and

MXH) will cross check to make sure there is no mistake. In case of disagreements, two

reviewers (DLZ and MXH) will resolve through discussion or a third reviewer (SLZ)

will be involved.


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http://www.ClinicalTrial.gov

http://www.chictr.org.cn.


8

The Cochrane risk of bias tool (www.cochrane-handbook.org.)42 will be used to assess

the risk of bias including the following items: random sequence generation, allocation

concealment, blinding of participants and personnel, blinding of outcome assessment,

incomplete outcome data, selective reporting and other bias. If the study meets all

criteria, it will be categorized as low risk of bias; the trials with insufficient information

to judge will be categorized as unclear risk of bias; the trials that meet none of the

criteria will be categorized as high risk of bias. Two reviewers (XCL and JL) will assess

the risk of bias independently then cross check to make sure no mistake. In case of

disagreements, two reviewers (XCL and JL) will resolve through discussion or a third

reviewer (RJJ) will be involved. Review Manager V5.3 software will be used to make

bias risk diagram.


To help health professional make decisions regarding individual patients, two qualified

reviewers (JY and JL, who were certificated by Chinese Cochrane Centre) will

independently evaluate the quality of evidence for outcomes by using the

Grades of Recommendations, Assessment, Development and Evaluation (GRADE)

system (http://www.gradeworkinggroup.org/society/index.htm). The GRADE includes

the following five aspects: limitations in study design, inconsistency, indirectness,

imprecision, and publication bias43. The quality of evidence will be graded as ‘high’,

‘moderate’, ‘low’ or ‘very low’ in accordance with the GRADE rating standards44. The

results of GRADE including evidence profile (EP) and summary of finding table (SoF)

will be generated using GRADE pro software.

2.9 Patient and public involvement

No patients were involved in writing this protocol of NMA. However, the results will

be disseminated to post-stroke patients suffering from balance impairment.


Pairwise meta-analysis

The characteristics of the included RCTs will be summarized. The clinical

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heterogeneity in the included RCTs will be checked through examination of patients’

baseline characteristics. For continuous data, standardized mean difference (SMD) will

be calculated; for dichotomous data, odds ratios (OR) will be computed. Statistical

heterogeneity across trials will also be assessed with the I2 statistics. If the P value is

≥0.1 and I2 ≤50%, we will synthesize SMD or OR with Mantel–Haenszel method (fixed

effects model). If the P value is <0.1 and I2 >50%, the Der Simonian-Laird method

(random-effects model) will be used.


The Bayesian network analysis will be conducted to compare the effects of different

rehabilitation therapies. The Markov Chain Monte Carlo (MCMC) algorithm will be

performed. A total of 5000 simulations for each chain will be defined as the ‘burn-in’

period. Then, posterior summaries will be based on 200 000 subsequent simulations.

The Brooks–Gelman–Rubin plots method will be used to assess model convergence.

The node splitting will be performed to check inconsistency when compare the indirect

evidence with direct evidence. We will adopt the deviance information criterion (DIC)

to explore the model fitness, in which the fixed and random effects model will be

compared.

Since primary outcomes are continuous data, the effect size of the rehabilitation

therapies will be calculated with the standardized mean difference (SMD) with 95%

confidence intervals (CIs), while dichotomous outcomes will be presented as OR with

95% CIs. The 95% CIs of each SMD will also be calculated.



therapies. A rankogram plots will show the probabilities for rehabilitation therapies to

assume any of the possible rank. SUCRAs will be present as percentage. 100% for the

best treatment while 0% for the worst. Data analysis will be performed using WinBUGS

1.4.3 and R software.

We will perform a narrative review and summarize the evidences, if the available data

are not suitable for synthesis.

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If the extracted data is missing, the original authors will be contacted for more

information. If there were no reply from the original authors, we will try to calculate

the data through the available coefficients, the potential impact of these missing data

on the results of the NMA will be tested in the sensitivity analysis.

Subgroup analysis

Subgroup analysis will be performed to address the potential heterogeneity and

inconsistency. Subgroup analysis will be performed based on age, gender, type of stroke,

disease course of stroke, the severity of balance impairment, the duration of treatment.

Also, the network meta regression will be conducted to explore the possible sources of

heterogeneity.


Sensitivity analysis of primary outcomes will be carried out to verify the robustness of

the study conclusions, assessing the impact of methodological quality, study design,

sample size and the effect of missing data as well as the analysis methods on the result

of this review.


For publication bias, each included study will be assessed according to the CONSORT

criterial. The Egger’s test will be conducted to check whether there is a statistical

significance. If the number of trials reporting the primary outcomes was 10 or more,

funnel plot will be performed to assess the publication bias of the included studies. If

funnel plots are asymmetric, we will try to interpret funnel plot asymmetry45.

3 Discussion

Balance impairment is one of the common impairments in patients after stroke, which

are related to worse physical impairments, disability and low quality of life. Moreover,

balance impairment often leads to high fall rates, which brings great burden to stroke

patients, families and society. In addition, good balance ability is the prerequisite for

recovering the ability of independent walking and activities of daily living.

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Current rehabilitation therapies including WBV, VR, exercise, MT, AFO, TCM, TCE

have been used to improve the balance ability of stroke patients. Several meta-analyses

of head to head comparisons have been carried out to investigate the comparative

efficacy and safety of these rehabilitation therapies. However, previous meta-analyses

failed to assess the comparative efficacy and acceptability of all the available

rehabilitation therapies. NMA is needed to determine the comparative effects of these

rehabilitation therapies.

To our knowledge, this will be the first NMA to investigate the rehabilitation therapies

for balance impairment in patients after stroke. On the basis of comparative

effectiveness evidence, this NMA is expected to provide a ranking of these therapies

for balance impairment in stroke patients. The results of this NMA could help the

patients and therapists to choose their best preference for balance impairment.

Moreover, we also hope that the results of this study may provide evidence for the

guidelines recommendations.


Ethics approval is not required in NMA. The results will be reported in accordance with

PRISMA. The findings will be submitted to peer review journal or conference.

Contributors: JL, DLZ and JY contributed equally to the work as first authors.

Study concept and design: RJJ and SLZ.

Acquisition of data: JL, DLZ, MXH, HZ and XCL.

Drafting of the manuscript: JL, DLZ and JY.

Critical revision of the manuscript for important intellectual content: All authors.

Supervision: RJJ.

All authors approved the publication of this protocol.

Acknowledgments

We would like to explicitly thank Yu Hu from Cardiff University for language

copyediting.


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Data sharing statement: No additional data.


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37. Hui-Fen M, I-Ping H, Pei-Fang T, et al. Analysis and comparison of the psychometric

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41. Weng C S TZ, Min L I. The value of the timed “up and go” test at the evaluation of functional

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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in patients with stroke (Abbreviation: CBM: China Biology Medicine disc, CNKI: China National Knowledge Internet, VIP: the Chinese Science and Technology Periodical Database)

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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in post-stroke patients (Abbreviation: CBM: China Biology Medicine disc, CNKI: China National Knowledge Internet, VIP:

the Chinese Science and Technology Periodical Database)

101x101mm (300 x 300 DPI)

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Appendix Ⅰ. search strategy.

number Search terms

1 cerebrovascular disorders OR cerebrovascular OR brain ischemia OR stroke OR

brain infarction OR CVA OR post-stroke OR poststroke OR cerebrovasc* OR

hemiplegia

2 balance OR posture OR postural balance OR balance impairment OR equilibrium

OR weight bearing OR weight shift OR postural control OR postural stability OR

postural instability OR postural disorders

3 physical therapy OR physical therapy modality OR physical therapy techniques OR

physiotherapy OR group physiotherapy OR neurological physiotherapy OR

neurophysiotherapy OR exercise movement techniques OR neurorehabilitation OR

rehabilitation

4 whole body vibration OR plantar vibration OR weight movement training weight

shift training OR treadmill training OR balance training OR balance exercises OR

ankle proprioceptive control OR virtual reality OR mirror therapy OR biofeedback

OR YOGA OR exercises OR training OR kinesiology taping OR orthosis

5 acupuncture OR electroacupuncture OR fire needle OR body acupuncture OR warm

needle OR auricular acupuncture OR Tuina OR Chinese tuina OR massage OR

massage therapy OR Chinese massage OR Chinese manipulation OR Chinese

manipulative therapy OR Chinese manipulation OR moxibustion OR Chinese

medicine OR traditional Chinese exercises

6 randomized controlled trial OR controlled clinical trial OR randomly OR

randomized OR randomized trial

7 1 AND 2 AND 3 AND 4 AND 5 AND 6

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Syst Rev. 2015;4(1):1.

Reporting Item

Page

Number




n/a



1/4




1



1




protocol amendments

n/a

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https://www.goodreports.org/prisma-p/info/#1a

https://www.goodreports.org/prisma-p/info/#1b

https://www.goodreports.org/prisma-p/info/#2







Role of sponsor or

funder

#5c Describe roles of funder(s), sponsor(s), and / or

institution(s), if any, in developing the protocol

-

Rationale #6 Describe the rationale for the review in the context of what

is already known

3-4

Objectives #7 Provide an explicit statement of the question(s) the review

will address with reference to participants, interventions,


4-6

Eligibility criteria #8 Specify the study characteristics (such as PICO, study

design, setting, time frame) and report characteristics (such

as years considered, language, publication status) to be

used as criteria for eligibility for the review

4-6

Information

sources

#9 Describe all intended information sources (such as

electronic databases, contact with study authors, trial

registers or other grey literature sources) with planned

dates of coverage

7



could be repeated

Appendix

/15

Study records -

data management



7

Study records -

selection process

#11b State the process that will be used for selecting studies

(such as two independent reviewers) through each phase

of the review (that is, screening, eligibility and inclusion in

meta-analysis)

7

Study records -

data collection

process


(such as piloting forms, done independently, in duplicate),

any processes for obtaining and confirming data from

investigators

7-8


(such as PICO items, funding sources), any pre-planned

data assumptions and simplifications

7

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https://www.goodreports.org/prisma-p/info/#5c











Outcomes and

prioritization


including prioritization of main and additional outcomes,

with rationale

5-6

Risk of bias in

individual studies



outcome or study level, or both; state how this information

will be used in data synthesis

7-8

Data synthesis #15a Describe criteria under which study data will be

quantitatively synthesised

8-9





8-9



10

#15d If quantitative synthesis is not appropriate, describe the

type of summary planned

10



studies)

10

Confidence in

cumulative

evidence



8




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https://www.goodreports.org/prisma-p/info/#15d



https://www.goodreports.org/

https://www.equator-network.org/

https://www.penelope.ai/

For peer review onlyRehabilitation for balance impairment in patients after

stroke: a protocol of a systematic review and network meta-analysis

Journal: BMJ Open

Manuscript ID bmjopen-2018-026844.R2


Date Submitted by the Author: 24-Apr-2019

Complete List of Authors: Li, Juan; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhong, Dongling; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationYe, Jing; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalHe, Mingxing; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationLiu, Xicen; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZheng, Hui ; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalJin, Rongjiang; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhang, Shao-lan; Chengdu Medical College, Immunology teaching and research section

<b>Primary Subject Heading</b>: Evidence based practice

Secondary Subject Heading: Rehabilitation medicine, Evidence based practice, Complementary medicine

Keywords:Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Rehabilitation medicine < INTERNAL MEDICINE, STROKE MEDICINE, THERAPEUTICS, COMPLEMENTARY MEDICINE


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Rehabilitation for balance impairment in patients after stroke: a

protocol of a systematic review and network meta-analysis

Juan Li1†, Dongling Zhong1†, Jing Ye2†, Mingxing He1, Xicen Liu1, Hui Zheng2, Rongjiang

Jin1*, Shaolan Zhang3*

1. School of Health Cultivation and Rehabilitation, Chengdu University of Traditional Chinese

Medicine, Chengdu, Sichuan, China

2. School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Chengdu

University of Traditional Chinese Medicine, Chengdu, Sichuan, China

3. Chengdu Medical College, Chengdu, Sichuan, China





Health Cultivation and Rehabilitation, Chengdu University of Traditional Chinese Medicine,

Chengdu, Sichuan, 610075, China; Chengdu Medical College, Chengdu, Sichuan, 610500, China.


Abstract

Introduction

Multiple rehabilitation therapies have been reported to be effective for post-stroke

balance impairment. However, the comparative effectiveness of these rehabilitation

therapies is still unclear. Therefore, the aim of this study is to summarize evidence

and identify the most effective rehabilitation therapy for post-stroke balance

impairment.


The following databases will be searched: China Biology Medicine (CBM), China

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National Knowledge Infrastructure (CNKI), Wan Fang Data, the Chinese Science and

Technology Periodical Database (VIP), Medline, EMBASE, Web of Science, The

Cochrane Library from inception to June 2019. All randomized controlled trials

(RCTs) that have utilized rehabilitation interventions to treat post-stroke balance

impairment will be included. The primary outcomes are the Berg Balance Scale

(BBS), the Fugl-Meyer Assessment (FMA (balance)), the Postural Assessment Scale

for Stroke (PASS), as well as the Function In Sitting Test (FIST), the Sitting Balance

Scale (SBS), the Ottawa Sitting Scale, the Activities-specific Balance Confidence

scale (ABC), the Overall Balance Index (OBI) and the Brunel Balance Assessment

(BBA). The secondary outcomes include the Barthel Index (BI), The Functional

Ambulation Category Scale (FAC), fall rates, the Timed Up-and-go test (TUG), the

MOS 36-item short-form health survey (SF-36), and adverse events. To ensure that all

relevant studies will be included without personal bias, study selection, data extraction

and quality assessment will be performed independently by two reviewers. Risk of

bias will be assessed with the Cochrane risk of bias assessment tool. Review Manager

V5.3 software will be used to make bias risk diagram and pairwise meta-analysis,

while network data synthesis will be performed using WinBUGS 1.4.3 and R

software.


Ethics approval is not required in systematic review and network meta-analysis. The

results will be submitted to a peer review journal.


Strengths and limitations of this study

This study will be the first network meta-analysis to compare the effectiveness

and safety of different rehabilitation physiotherapists for post-stroke balance

impairment.

The results of this study will provide evidence for the management of balance

impairment and help the therapists and patients to choose suitable treatment.

To make sure that all relevant studies will be included without personal bias, two

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reviewers will perform the study selection, data extraction and quality assessment

independently.

Although both electronic search and hand search will be performed in this study,

potential unpublished trials are inevitable. To overcome this limitation, the

experts in this field will be consulted for unpublished trials.

Owing to the difficulty of locating all the effective rehabilitation therapies for

post-stroke balance impairment, we will review the guideline and consult the

experts for the recommended rehabilitation therapies.

1 Introduction

Stroke is a common clinical cerebrovascular disease, with high morbidity, mortality,

and disability rates, which brings a heavy economic burden to society and families1-3.

Balance is the ability to maintain the line of gravity within the base of support with

minimal postural sway4. The control of human balance is a comprehensive process

relying on the integration of visual, vestibular and somatosensory inputs in the central

nervous system. It is reported that about 83% of stroke survivors suffered from

balance impairment. Balance impairment is characterized by short supporting time

and differences between two sides of the body and slow walking speed, which may

increase the risk of falls5. Fear of falling can contribute to sedentary lifestyle and

increased disability, which means lower quality of life6. Falling often leads to longer

hospital stay, more medical and nursing costs, and economic losses directly or

indirectly. In China, annual medical expenses caused by cerebrovascular falls exceed

5 billion yuan, resulting in a direct or indirect social cost of approximately 160 to 80

billion yuan7. Therefore, management of balance impairment is challenging for

patients with stroke.

Numerous rehabilitation therapies have been used to improve balance ability of stroke

patients including whole body vibration (WBV)8, virtual reality (VR)9 10, exercise11,

mirror therapy (MT)12-14, traditional Chinese medicine (TCM)15, traditional Chinese

exercise (TCE)16-18, ankle-foot orthosis (AFO)19 and so on. WBV is able to improve

results of the Functional Reach Test and the Timed Up-and-go test (TUG), which has

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a positive effect on the balance and gait function of stroke patients20. Results of an

RCT concluded that VR is an effective rehabilitation therapy which can improve

postural balance and upper extremity function in post-stroke patients21. Exercises such

as bilateral upper extremity exercises22, step climbing exercise23 and trampoline

training24 are beneficial for balance ability and fall prevention. Recent systematic

reviews and meta-analyses showed that MT can improve balance, mobility, gait

speed, and motor function compared to control groups12-14. AFO is capable to improve

the gait and balance in patient with balance impairment after stroke25. Acupuncture is

an important part of TCM, which has been used to restore limb movement and

balance disability in patients with stroke15. Results from several meta-analyses

showed that TCE including Tai Chi, Baduanjin, Yijinjing, Liuzijue and so on can

effectively enhance the balance ability by increasing the Berg Balance Scale (BBS)

score and reducing fall rate16.

Based on these grounds, we raise an important clinical question: among these

rehabilitation therapies, which is the most comparative effective and safe therapy to

enhance balance ability for post-stroke patients. Different from traditional pairwise

meta-analysis, network meta-analysis (NMA) is capable to summarize the direct and

indirect evidence and evaluate the relative efficacy of multiple treatment comparisons.

What is more, NMA is able to provide the ranking of treatment options based on their

effectiveness. Therefore, to help physiotherapists and patients make better choice in

improving balance, a systematic review and NMA should be conducted to summarize

the evidence of various rehabilitation therapies and to identify the most effective

rehabilitation therapy for post-stroke balance impairment.

2 Methods

2.1 Registration

The protocol of this systematic review and NMA has been registered at the

international prospective register of systematic reviews (PROSPERO,

http://www.crd.york.ac.uk/PROSPERO). The registration number of this NMA is

CRD 42018107441. The protocol will be reported in accordance with the guidelines

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http://www.crd.york.ac.uk/PROSPERO


5

of the Preferred Reporting Item for Systematic Review and Meta-analysis Protocols

(PRISMA-P). The procedure of this review is shown in figure 1.


Type of studies

Only randomized controlled trials (RCTs) will be included. Trials without control

group or those with quasi-random allocation will be excluded. No restrictions on

language or publication date.

Types of participants

We will include RCTs that involved post-stoke patients diagnosed according to the

stroke diagnostic criteria formulated by The Fourth National Cerebrovascular Disease

Conference in 199526, A Guide to the Prevention and Treatment of Chinese




Medicine in 199628. Diagnosis of stroke are summarized as following: Clear stroke

history and manifestations, supported by imaging examination such as cranial plain

Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI). There will

be no restriction on age, sex and race.

Types of interventions

Experts were consulted for the recommended rehabilitation therapies. All kinds of

rehabilitation therapies for post-stroke balance impairment including traditional

Chinese medicine therapies (such as acupuncture, moxibustion, Tai Chi and so on)

and modern rehabilitation therapies (which refer to physical therapies defined by the

World Confederation for Physical Therapy (WCPT)

(http://www.wcpt.org/policy/ps-descriptionPT)), typically including balance-specific

activities (such as balance exercises, weight shift training and so on), more general

activities (such as strengthening exercises, gait activities and so on), biofeedback,

WBV, VR, MT, orthosis and so on.


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Primary outcomes will focus on balance ability. Secondary outcomes will include

functional ambulatory ability as well as quality of life.

Primary outcomes

The primary outcomes include BBS, the Postural Assessment Scale for Stroke (PASS)

and the Fugl-Meyer Assessment (FMA(balance))29, as well as the Function In Sitting

Test (FIST), the Sitting Balance Scale (SBS), the Ottawa Sitting Scale, the

Activities-specific Balance Confidence (ABC) scale, the Overall Balance Index (OBI)

and the Brunel Balance Assessment (BBA).

BBS assesses the functional postural abilities of patients in several conditions (lying

on the back, sitting, standing, leaning forward, change of position and so on). This

scale is composed of 14 items. The maximal score, reflecting the best functional

postural abilities, is 56 points30-32. FMA (balance) as a method for assessing the

balance was developed from the Brunnstrom Level 6 functional grading. This scale is

composed of 7 items with 3 levels. The maximal score is 14 points. Lower score

means more severe balance impairment33. PASS was developed specifically for

assessing balance in stroke patients. PASS demonstrates high reliability34, favorable

individual item agreement35, and high test-retest reliability36 37. FIST and SBS both

are scales related to sitting. FIST is a performance-based measure to examine deficits

in seated postural control, which consists of 14 items38, while SBS measures sitting

balance for frail older adults39. ABC scale is a method of balance confidence

evaluation, demanding participants to choose one of percentage points on the scale

from 0% to 100% in 16 items40. OBI is an index to evaluate the ability of controlling

balance in all directions41. BBA is a measure of balance disability post stroke, which

consists of 12 items in three areas (sitting balance, standing balance, walking

function)42.

Secondary outcomes

The secondary outcomes will include the Barthel Index (BI), The Functional

Ambulation Category Scale (FAC), fall rates, TUG, The MOS 36-item short-form

health survey (SF-36), adverse events.

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BI is used as standard measures for activities of daily living and motor function43.

FAC is an assessment tool designed to categorize functional ambulation ability. TUG

is a simple test used to assess a person's mobility and requires both static and dynamic

balance44. SF-36 is a health survey questionnaire, which consists of 36 items in areas

of functional status, well-being, overall evaluation of health and health compared to

one year ago.


The following will be excluded: ①Study types as following: reviews, cluster RCTs,

cross-over designs, cohort or case-control studies. ②balance impairment not caused

by stroke, for example, caused by Parkinson’s disease, pediatric cerebral palsy, knee

surgery or other diseases. ③duplicate or un-extracted data. ④No access to obtain

full text.

2.4 Data sources and search

Medline, EMBASE, Web of Science, The Cochrane Library, China National

Knowledge Infrastructure (CNKI), China Biology Medicine (CBM), Wan Fang Data

and the Chinese Science and Technology Periodical Database (VIP) databases will be

searched from inception to June 2019. RCT registration website, including

http://www.ClinicalTrial.gov and http://www.chictr.org.cn. will also be searched.

Supplements like magazines, websites and references list of identified publications

will also be searched for candidates. Experts in this field will be consulted for

unpublished trials. Search strategy will be designed by a professional medical

librarian (HZ), which can be seen in AppendixⅠ.


All the retrieved studies will be imported into Endnote(X8) and the duplicated studies

will be deleted. Two reviewers (DLZ and JY) will screen the titles and abstracts

independently in accordance with the inclusion and exclusion criteria, then cross

check. Two reviewers (DLZ and JY) will download the full texts of all possibly

relevant studies for further assessment independently then cross check. Team

discussion or consulting a third reviewer (JL) will be used to resolve disagreements.

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http://www.ClinicalTrial.gov

http://www.chictr.org.cn.


8

2.6 Data extraction

Two reviewers (DLZ and JY) will independently extract information using an

advance-designed standardized data extraction form. The extract information include

study characteristics (author and year of publication), participants (sample size, sex,

age, type of stroke, location of lesion, disease course, times of strokes and so on),

interventions (frequency, duration, study period and so on), comparisons (frequency,

duration, study period and so on), outcomes (BBS, FMA (balance), BI, SF-36 and so

on) and adverse events of the included studies. Then two reviewers (DLZ and JY) will

cross check to make sure there is no mistake. Disagreements will be resolved by team

discussion.


Risk of bias will be assessed in accordance with the Cochrane risk of bias tool

(www.cochrane-handbook.org.)45, which includes the following items (random

sequence generation, allocation concealment, blinding of participants and personnel,

blinding of outcome assessment, incomplete outcome data, selective reporting and

other bias). The assessment of each item can be rated as ‘low risk of bias’, ‘unclear

risk of bias’ and ‘high risk of bias’, ‘low risk of bias’ means the study meets all

criteria, ‘unclear risk of bias’ means the study with insufficient information to judge,

‘ high risk of bias’ indicates the study meet none of the criteria. Two reviewers (XCL

and JL) will assess the risk of bias independently, then cross check to make sure no

mistake. Disagreement will be settled by consulting a third reviewer (RJJ). Review

Manager V5.3 software will be used to make bias risk diagram.


Two qualified reviewers (DLZ and JL, who were certificated by Chinese GRADE

Centre in Lanzhou) will independently evaluate the quality of evidence for outcomes

by using the Grades of Recommendations, Assessment, Development and Evaluation

(GRADE) system (http://www.gradeworkinggroup.org/society/index.htm). The

GRADE includes the following five aspects: limitations in study design,

inconsistency, indirectness, imprecision, and publication bias46. The quality of

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evidence will be graded as ‘high’, ‘moderate’, ‘low’ or ‘very low’ in accordance with

the GRADE rating standards47. The results of GRADE including evidence profile

(EP) and summary of finding table (SoF) will be generated using GRADE pro

software.

2.9 Patient and public involvement

No patients were involved in writing this protocol of systematic review and NMA.

However, the results will be disseminated to post-stroke patients suffering from

balance impairment.


Pairwise meta-analysis

The characteristics of the included RCTs will be summarized. The clinical

heterogeneity in the included RCTs will be checked through examination of patients’

baseline characteristics. For continuous data, standardized mean difference (SMD)

will be calculated; for dichotomous data, odds ratios (OR) will be computed.

Statistical heterogeneity across trials will also be assessed with the I2 statistics. If the

P value is ≥0.1 and I2 ≤50%, we will synthesize SMD or OR with fixed effects model

(FEM). If the P value is <0.1 and I2 >50%, the random-effects model (REM) will be

used.


The Bayesian network analysis will be conducted to compare the effects of different

rehabilitation therapies. The Markov Chain Monte Carlo (MCMC) algorithm will be

performed. A total of 5000 simulations for each chain will be defined as the ‘burn-in’

period. Then, posterior summaries will be based on 200 000 subsequent simulations.

The Brooks–Gelman–Rubin plots method will be used to assess model convergence.

The node splitting will be performed to check inconsistency when compare the

indirect evidence with direct evidence. We will adopt the deviance information

criterion (DIC) to explore the model fitness, in which the fixed and random effects

model will be compared.

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Since primary outcomes are continuous data, the effect size of the rehabilitation

therapies will be calculated with the standardized mean difference (SMD) with 95%

confidence intervals (CIs), while dichotomous outcomes will be presented as OR with

95% CIs. The 95% CIs of each SMD will also be calculated.



therapies. A rankogram plots will show the probabilities for rehabilitation therapies to

assume any of the possible rank. SUCRAs will be present as percentage, 100% for the

best treatment while 0% for the worst. Data analysis will be performed using

WinBUGS 1.4.3 and R software. We will perform a narrative review and summarize

the evidences, if the available data are not suitable for synthesis.


The original authors will be contacted for more information of the missing data. In the

absence of a reply, we will try to calculate the data through the available coefficients,

the potential impact of these missing data on the results of the NMA will be tested in

sensitivity analysis.

Subgroup analysis

Subgroup analysis will be performed to address the potential heterogeneity and

inconsistency. Subgroup analysis will be performed based on age, gender, type of

stroke, disease course of stroke (within 6 months or after 6 months), location of

lesion, times of stroke, the severity of balance impairment (BBS will be taken to

define the severity of balance impairment. 0~20: poor balance ability; 20~40: fair

balance ability; 41~56: good balance ability) and the duration of treatment.

Meanwhile, the network meta regression will be conducted to explore the possible

sources of heterogeneity.


To verify the robustness of the study conclusions, sensitivity analysis of primary

outcomes will be carried out, assessing the impact of methodological quality, study

quality, sample size and the effect of missing data as well as the analysis methods on

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the result of this review.


Each included study will be assessed according to the CONSORT criterial. The

Egger’s test and funnel plot will be conducted to assess the publication bias of the

included studies for primary outcomes. If funnel plots were asymmetric, we will try to

interpret funnel plot asymmetry48.

3 Discussion

Balance impairment is one of the common impairments in patients after stroke, which

is related to worse physical impairments, disability and low quality of life. Moreover,

balance impairment often leads to high fall rates, which brings great burden to stroke

patients, families and society. In addition, good balance ability is the prerequisite for

recovering the ability of independent walking and activities of daily living.

Current rehabilitation therapies including WBV, VR, exercise, MT, AFO, TCM, TCE

have been used to improve the balance ability of stroke patients. Several

meta-analyses of head to head comparisons have investigated the comparative

efficacy and safety of these rehabilitation therapies. So far, no NMA has been

conducted to assess the comparative efficacy and acceptability of all the available

rehabilitation therapies. Therefore, NMA is needed to determine the comparative

effects of these rehabilitation therapies.

To our knowledge, this will be the first systematic review and NMA to investigate the

rehabilitation therapies for balance impairment in patients after stroke. On the basis of

comparative effectiveness evidence and safety, this NMA is expected to provide a

ranking of these therapies for balance impairment in stroke patients. The results of

this NMA could help the patients and therapists to choose their best preference for

balance impairment. Moreover, we also hope that the results of this study may provide

evidence for the guidelines recommendations.


Ethics approval is not required in NMA. The results will be reported in accordance

with PRISMA. The findings will be submitted to peer review journal or conference.

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Contributors: JL, DLZ and JY contributed equally to the work as first authors.

Study concept and design: RJJ and SLZ.

Acquisition of data: JL, DLZ, MXH, HZ and XCL.

Drafting of the manuscript: JL, DLZ and JY.

Critical revision of the manuscript for important intellectual content: All authors.

Supervision: RJJ.

All authors approved the publication of this protocol.

Acknowledgments

We would like to explicitly thank Yu Hu from Cardiff University for language

copyediting.




Data sharing statement: No additional data.


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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in patients with stroke (Abbreviation: CBM: China Biology Medicine, CNKI: China National Knowledge Infrastructure, VIP: the Chinese Science and Technology Periodical Database)

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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in post-stroke patients (Abbreviation: CBM: China Biology Medicine, CNKI: China National Knowledge Infrastructure, VIP:

the Chinese Science and Technology Periodical Database)

101x101mm (300 x 300 DPI)

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Appendix Ⅰ. search strategy.

number Search terms#1 cerebrovascular disorders OR cerebrovascular OR brain ischemia OR stroke OR

brain infarction OR CVA OR post-stroke OR poststroke OR cerebrovasc* OR hemiplegia

#2 balance OR posture OR postural balance OR balance impairment OR equilibrium OR weight bearing OR weight shift OR postural control OR postural stability OR postural instability OR postural disorders

#3 physical therapy OR physical therapy modality OR physical therapy techniques OR physiotherapy OR group physiotherapy OR neurological physiotherapy OR neurophysiotherapy OR exercise movement techniques OR neurorehabilitation OR rehabilitation

#4 whole body vibration OR plantar vibration OR weight movement training weight shift training OR treadmill training OR balance training OR balance exercises OR ankle proprioceptive control OR virtual reality OR mirror therapy OR biofeedback OR YOGA OR exercises OR training OR kinesiology taping OR orthosis

#5 acupuncture OR electroacupuncture OR fire needle OR body acupuncture OR warm needle OR auricular acupuncture OR Tuina OR Chinese tuina OR massage OR massage therapy OR Chinese massage OR Chinese manipulation OR Chinese manipulative therapy OR Chinese manipulation OR moxibustion OR Chinese medicine OR traditional Chinese exercises

#6 randomized controlled trial OR controlled clinical trial OR randomly OR randomized OR randomized trial

#7 #1 AND #2 AND (#3 OR #4 OR #5) AND #6

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Syst Rev. 2015;4(1):1.

Reporting Item

Page

Number




n/a



1/4




1



1




protocol amendments

n/a

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Role of sponsor or

funder

#5c Describe roles of funder(s), sponsor(s), and / or

institution(s), if any, in developing the protocol

-

Rationale #6 Describe the rationale for the review in the context of what

is already known

3-4

Objectives #7 Provide an explicit statement of the question(s) the review

will address with reference to participants, interventions,


4-6

Eligibility criteria #8 Specify the study characteristics (such as PICO, study

design, setting, time frame) and report characteristics (such

as years considered, language, publication status) to be

used as criteria for eligibility for the review

4-6

Information

sources

#9 Describe all intended information sources (such as

electronic databases, contact with study authors, trial

registers or other grey literature sources) with planned

dates of coverage

7



could be repeated

Appendix

/15

Study records -

data management



7

Study records -

selection process

#11b State the process that will be used for selecting studies

(such as two independent reviewers) through each phase

of the review (that is, screening, eligibility and inclusion in

meta-analysis)

7

Study records -

data collection

process


(such as piloting forms, done independently, in duplicate),

any processes for obtaining and confirming data from

investigators

7-8


(such as PICO items, funding sources), any pre-planned

data assumptions and simplifications

7

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Outcomes and

prioritization


including prioritization of main and additional outcomes,

with rationale

5-6

Risk of bias in

individual studies



outcome or study level, or both; state how this information

will be used in data synthesis

7-8

Data synthesis #15a Describe criteria under which study data will be

quantitatively synthesised

8-9





8-9



10

#15d If quantitative synthesis is not appropriate, describe the

type of summary planned

10



studies)

10

Confidence in

cumulative

evidence



8




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https://www.goodreports.org/prisma-p/info/#15d



https://www.goodreports.org/

https://www.equator-network.org/

https://www.penelope.ai/

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