An Update in Robotics in

Outpatient Rehab

Kristen Black-Bain PT, DPT, NCS

Objectives

• Be familiar with various robotic devices for

both upper and lower extremities.

• Be familiar with current research on

various robotic devices for both upper and

lower extremities.

• Learn about advances in exoskeleton

development

If a robot does “the

robot”, is it still

called “the robot”?

Or just dancing??

• Robotics in Rehab

– Mobility aids

– Manipulation aids

– Evaluation tools

– Therapeutic aids

Motor Learning

Repetition

Specificity

Intensity

Use it or Lose it

Use it & Improve

itTime

Feedback

Transference

Interference

Robotics in Rehab

• Fewer therapists/staff

• Active participation with progression

• Reproducible

• Mental well being

Lower Extremity Robots

LE Robots

Alter G

Bionic Leg

G-EO

Lokomat Pro

Upper Extremity Robots

UE Robots

ARMEO Power

ReoGo

InMotion ARM

Research

• Veterans Administration/Department of Defense, regarding UE

robotics, “recommend robot-assisted movement therapy as an

adjunct to conventional therapy in patients with deficits in arm

function to improve motor skill” (Krebs, 2012).

• “American Heart Association suggests that robot-assisted therapy

for the UE has achieved Class I level of evidence for stroke care in

outpatient and chronic care setting… Class IIa for stroke care in

inpatient setting” (Krebs, 2012).

• Study of 10 chronic SCI (C4-C6) participating in 6 wk study

showed clinically significant improvements in aim and smoothness

of movement in UE kinematics (Cortes, 2013).

Research

• RCT; Subacute (30 + 7 days) stroke patients; showed significant

improvement in Fugl-Meyer, MAS, and PROM after robot-assisted

upper limb rehab tx (Sale, 2014).

– Control group performing standard therapy also showed

significant improvement in Fugl-Meyer but experimental group

had higher improvement

• Single-blind RCT; children with CP improved significantly in

manual dexterity assessed by Box and Block test compared with

control group (Gilliaux, 2015).

• Single-blind RCT; chronic stroke patients had significant

improvement in task-oriented arm training after six months

(Timmermans, 2014)

Device Function Cost Features

ARMEO Intelligent arm support in

3D workspace, 6

actuated DOF,

augmented feedback,

provides objective data

$190,000 Pediatric option,

more degrees of

freedom

Reo-Go 3D gyro mechanism;

performance feedback,

collects objective data

$85,000 Mobile/easy to

move; lock out

specific motions

InMotion 2 active DOF at

shoulder;

$110,000- ARM and

Hand.

Additional $90,000 for

InMotion Wrist

Optional InMotion

Hand and Wrist for

combined

coordination of

movement.

Pediatric option

Hybrid UE Robot Research

• MAHI-EXO II

– Upper extremity exoskeleton

– 5 degrees of freedom

– Hard stop at elbow

– Currently conducting validation studies

for patients with Stroke and SCI

MAHI-EXO II + BCI (Brain Computer Interface)

– Currently recruiting subacute and chronic

stroke participants

https://clinicaltrials.gov/ct2/show/NCT01948739

Photo courtesy of www.neurogadget.com

Lower Extremity Exoskeletons

Exoskeletons

ReWalk Ekso Rex

Ekso• Formerly called “E-Legs”

• Wearable bionic suit that enables user to stand and walk over

ground

• Battery powered motors move limbs in reciprocal gait pattern

• Progressing walking modes

– Training mode with audio feedback for appropriate weight shifting

• Variable assist

– Various settings that

allow range of passive

to actively assisted

stepping from user

• Bilateral Max Assist

• Adaptive Assist

• Fixed Assist Photo courtesy of www.prescouter.com

Research• Clinical trials out of Kessler showing positive results from training with

Ekso exoskeleton (presented at ASCIP 2012, 2014 conference by Gail

Forrest, PhD)

– Increased oxygen consumption, ventilation, and heart rate showing

potential cardiovascular benefit

– Increased muscle firing in lower leg muscles during Ekso assisted

walking

– Increase gait speed and decreased stance time on single limb with

increased training

– Increased loading on LEs

Research• Clinical trials out of Mount Sinai (presented at ASCIP 2014 by Allan

Kozlowski, PT)

– Ekso walking is safe (no adverse events occurred)

– Level of assistance varies

– HR, RPE, METs comparable to light exercise

– Secondary benefits: reports of improved pain, spasticity, posture,

sleep, and bowel function

– Psychosocial benefits

Rex Bionics

• Hands free, self supported device controlled by joystick

• Can be used by people with cervical injuries

as high as C-4

• Can navigate up/down stairs and ramps

• Rehab and personal units available (UK only)

• Fast adjustability

Update:

• Clinical trials starting in early 2015

• Goal is to secure pre-market notification, 501(k)

from FDA by end of second quarter of 2016

leading to at-home use late 2016. Photo courtesy of www.proactiveinvestors.co.uk

ReWalk• Stepping is controlled by wt shifting and subtle trunk movements that

trigger tilt sensors

• Adjustability for varying levels of user (beginner – advanced)

– Joint range, step speed, delay between steps, tilt angle, current

threshold

• Battery held in backpack

• Able to ascend/descend stairs

• Used with forearm crutches

• Mode is determined by watch

controller worn by user

Only FDA approved device in US for personal usePhoto courtesy of www.medicalplasticnews.com

Research

• 6 Chronic SCI volunteer participants with thoracic level (T5- T12)

complete injuries participated in average 13 training sessions did

not show any increase in pain or adverse effects (Esquenazi, 2012)

– One participant with chronic high-level neuropathic pain (VAS 8-9)

showed repeated improvement after training (VAS 4-6).

• In a nonrandomized single intervention trial, 12 subjects with

chronic thoracic level (T3-T12) motor complete SCI reported

positive emotional/psychological benefits on survey (Zeilig, 2012)

– 3/11 reported improved spasticity, 0/11 reported increase in pain, 5/11

reported improved bowel regulation

Research

• Improved bowel function in 5 motor complete SCI participating in

15-20 sessions of ReWalk exoskeleton training (Fineberg, 2012)

– Decreased average time of evacuation

– reduction of dependency for manual stimulation, laxatives, or stool

softeners

• Early data out of Bronx VA (Ann Spungen, presented at ASCIP

2014); 7 ReWalk users walking 1-2 hours 3 days a week

– Improved skill level (decreased assistance, varied terrain outdoors, community

mobility)

– potential positive lean tissue mass changes in users with lower motor partial

zones of preservation

– No changes in bone mineral density

– Loss of fat mass

– Report of significant improvement in bowel function

– Increased energy expenditure but sustainable

– Improved QOL

Case Report

• Female 27 years old; Chronic T-10 AIS-C SCI, 10 years post injury

• Goal: to walk around home with braces (KAFO/AFO)

• Previously attempted ambulation with braces and FWW

– Subjective report: required assistance, relied heavily on UEs

allowing only 5-10 ft of gait with FWW

• Measurements before ReWalk training

– TUG: 52 sec; wearing R KAFO and L AFO in parallel bars

– LE MMT

• R hip flex 4-/5 L hip flex 4+/5

• R hip ext 2-/5 L hip ext 3-/5

• R knee ext 3-/5 L knee ext 5/5

• R knee flex 2/5 L knee flex 3/5

– Pain: daily nerve pain in B LEs L > R, worst 9/10 on VAS

Case Report

• Intervention

– 2-3 days/ week X 6 weeks

• 15 sessions total; 11 ReWalk, 4 gait training with braces

started after first 3 weeks

• Measurements after 6 weeks

– TUG: 23.72 sec (52.36 sec)

– Ambulate 77 (5-10) ft with FWW

– LE MMT

• R hip flex 4-/5 (4-) L hip flex 4+/5 (4+)

• R hip ext 2+/5 (2-) L hip ext 3-/5 (3-)

• R knee ext 3/5 (3-) L knee ext 5/5

• R knee flex 2/5 (2) L knee flex 3+/5 (3)

• Pain: daily nerve pain in B LEs; worst 8/10 VAS (9/10)

“When using the ReWalk I could feel my

abs starting to work and I hadn’t felt that

before.”

“Using it definitely helped with my sitting

balance”.

“Using the ReWalk has helped my trunk to

get stronger with other things I do”.

Hybrid-Exoskeletons

Indego HAL Kinesis/H2

H2-Exo / Kinesis

• Exoskeleton developed by Technaid out of Spain

• Bilateral lower extremity equipped with active

actuators at knee hinges

– Passive elastic actuators at ankles

• EMS: PC controlled stimulator delivers

biphasic current to knee ext/flex

• Can manually trigger steps

• Wearer uses walker for UE support

Research

• Pilot study; 3 motor incomplete SCI using FES hybrid

exoskeleton

– able to complete 6 minutes of walking after one day (Del Ama,

May 2014)

– After only one week of training, improved gait measures (10m

and 6MWT), but also continued to improved one week after

intervention.

• HYPER project

– Recruiting for clinical trial: Subacute or chronic stroke patients

– https://clinicaltrials.gov/ct2/show/NCT02114450

H2-Exo

Cyberdyne HAL

• Hybrid-Assistive-Limb

• “World’s First Cyborg type robot that

interfaces man, machine, and information”

• Assistance triggered by EMG

from surface electrodes

• Single LE, Bilateral LE, or whole body

UE/LE combo

• Currently only in Japan and Germany

• Submitted application for FDA

clearance in U.S. Photo courtesy of www.cyberdyne.jp

Research

• After 16 training sessions, patients with various

neurological diagnoses (Stroke, SCI) improved gait

speed, number of steps, and cadence (Kubota, 2013).

• HAL was found to be safe when used for gait training in

acute stroke patients (Nilsson, 2014)

– All 7 participants improved gait measured by 10MWT

Indego

• Lightweight at only 27 lbs

• Breaks down to smaller pieces for easy travel/transportation

• Functional electrical stimulation component

• Adapts to user input with varying levels of

power provided

• Requires use of AFO to be worn with device

Photo courtesy of www.mdtmag.com

Indego

• Slim profile that allows sitting in most standard wheelchairs

• Wireless operation through app

on mobile device

• Single handed strapping

• Not yet approved by FDA

• Commercial release expected

in 2016 in US

Photos courtesy of www.indego.com

Research

• Single subject case study showed exoskeleton powered

locomotion to have faster gait speed and also reduced

exertion compared with KAFO use (Farris, 2013).

• Single subject case study with T10 complete SCI using

exoskeleton combined with FES showed 34% reduction

in electrical power required at hip joints during stance

phase of gait (Ha, 2012)

Research

• Preliminary data presented at ASCIP 2014

– Potential for multiple dxs (SCI, CVA, TBI, MS, etc)

– Easy to learn for staff and family/caregivers

– Self report of reduced spasticity during and up to 4 hrs after

– Reduced pain and time for bowel care

• Recruiting for multi center clinical trial

– https://clinicaltrials.gov/show/NCT02202538

Device Function Cost Availability

Ekso Can balance indep, Sit to

stand, gait, progressing

level of independence

settings

Rehab Unit: approx-

$150,000

Currently only

rehab unit

available.

Indigo E-stim, sit to stand, gait,

stair climbing

Projected estimate:

approx- $30,000

Expecting FDA

approval 2016

HAL,

Cyberdyne

Sit to stand, gait, upper

and lower limb

assistance,

Facility contract rental

agreement: $5000

initial then approx-

$1400-$1600 per mo

Japan and

Germany, has

applied for FDA

approval in US

ReWalk Sit to stand, gait,

direction change, stair

climbing

Rehab Unit: approx-

$85,000

Personal Unit:

projected approx-

$65,000

Currently rehab

unit available.

Available for

purchase. VA has

covered one P unit

Rex Bionics Sit to stand, gait, stairs,

ramps up/down, no

assistive device

Both rehab and

personal units:

$150,000

Rehab unit avail

worldwide;

Personal- UK

3D Printing

Photo courtesy of www.dezeen.com

MindWalker Project

Photo courtesy of www.damngeeky.com

Walk Again

Criteria for Exoskeleton use

• Healthy weight

• Range of motion within normal limits

• Orthopedically stable

• Upright tolerance

• Device specific requirements

Contraindications:

- fractures, uncontrolled spasticity, pregnancy, skin breakdown, DVT,

low blood pressure, psychiatric/cognitive issues, contractures

Good Physical Health is the Key!!

Considerations when choosing a device

• Patient population

• Cost

• How will it be used/ Reimbursement

• The company providing and manufacturing the device.

• Space/ceiling height in your facility

Motor Learning

Repetition

Specificity

Intensity

Use it or Lose it

Use it & Improve

itTime

Feedback

Transference

Interference

Be Creative !

Think outside the box!

REFERENCES:• Bishop L, Stein J, Wong CK. Robot-aided gait training in an individual with chronic spinal cord injury: a

case study. JNPT. 2012;36: (138-143).

• Byl NN. Mobility training using a bionic knee orthosis in patient in a post-stroke chronic state: a case

series. Journ of Medical case report. 2012; 6:216.

• Cortes M, et al. Improved motor performance in chronic spinal cord injury following upper-limb robotic

training. Neuro Rehabil. 2013; 33 (57-65).

• del-Ama AJ, Gil-Agudo A, Pons JL, Morena JC. Hybrid FES-robot cooperative control of ambulatory gait

rehabilitation exoskeleton. J Neuroeng Rehabil. 2014 Mar 4; 11:27.

• del-Ama AJ, Gil-Agudo A, Pons JL, Moreno JC. Hybrid gait training with an overground robot for people

with incomplete spinal cord injury: a pilot study. Front Hum Neurosci. 2014 May 13; 8:298.

• Esquenazi A, Packel A. Robotic-Assisted gait training and restoration. Am J Phys Med Rehabil. 2012; 91

(Suppl), 217-231.

• Esquenazi A, Talaty M, Packel A, Saulino M; The ReWalk powered exoskeleton to restore ambulatory

function to individuals with thoracic-level motor-complete spinal cord injury. Am Journ Phys Med Reh.

2012 Nov; 91: 11 (911-21).

• Farris R, et al. A preliminary assessment of legged mobility provided by a lower limb exoskeleton for

persons with paraplegia. IEEE Trans Neural Syst Rehabil Eng. 2013; 18.

• Fineberg DB, et al. Improvements in bowel function in paraplegics using ReWalk for overground

ambulation. Poster presentation. Academy of spinal cord injury professionals. Annual conference 2012.

• Fineberg DB, Asselin P, Harel NY, Agranova-Breyter I, Kornfeld SD, Bauman WA, Spungen AM. Vertical

ground reaction force-based analysis of powered exoskeleton-assisted walking in persons with motor-

complete paraplegia. Journ Spinal Cord Med. 2013, 36:4, 313-321.

• Gilliaux M, Renders A, Dispa D, Holvoet D, Sapin J, Dehez B, et al. Upper limb robot-assisted therapy in

cerebral palsy: a single-blind randomized controlled trial. Neurorehabil Neural Repair. 2015 Feb; 29(2):

183-92.

• Ha KH, Quintero HA, Farris RJ, Goldfarb M. Enhancing stance phase propulsion during level walking by

combining FES with a powered exoskeleton for persons with paraplegia. IEEE Eng Med Biol Soc. 2012;

2012:344-7.

• Herr H. Exoskeletons and orthoses: classification, design challenges and future directions. Journ of

NeuroEng and Rehab. 2009, 6:21.

• Hesse S, Werner C, Bardeleben A. Electromechanical gait training with functional electrical stimulation:

case studies in spinal cord injury. Spinal Cord. 2004.

• Hesse S, Waldner A, Tomelleri C. Innovative robot for the repetitive practice of floor walking and stair

climbing up and down in stroke patients. J Neuroeng Rehabil. 2010 Jun. 7:30.

• Hidler J, et al. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in

subacute stroke. Neurorehabil Neural Repair. 2009; 23(1), 5-13.

• Hornby TG, et al. Enhanced gait-related improvements after therapist-versus robotic-assisted locomotor

training in subjects with chronic stroke: A randomized controlled study. Stroke. 2008; 39(6), 1768-92.

• Krebs HI, Hogan N. Robotic therapy: the tipping point. Am J Phys Med Rehabil. 2012 Nov. 91: 11 03,

(S290-S297).

• Kubota S, et al. Feasibility of rehabilitation training with a newly developed wearable robot for patients

with limited mobility. Arch Phys Med Rehabil. 2013 Jun. 94: 6 (1080-7).

• Mayr A, Kofler M, Qirbach E, et al. Prospective, blinded, randomized crossover study of gait

rehabilitation in stroke patients using the Lokomat gait orthosis. Neurorehabil Neural Repair. 2007;

21:307-14.

• McCabe J, Monkiewicz M, Holcomb J, Pundik S, Daly JJ; Comparison of Robotics, FES, and Motor

Learning Methods for Treatment of Persisten Upper Extremity Dusfunction after Stroke: a Randomized

Controlled Trial. Arch Phys Med Rehabil. 2014 Nove 15.

• Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a

new exoskeleton- the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. 2014

June 2; 11:92.

• Nooijen CF, et al. Gait quality is improved by locomotor training in idividuals with SCI regardless of

training approach. J Neuroeng Rehabil. 2009; 6:36.

• Norouzi-Gheidari N, et al. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs:

systematic review and meta-analysis of the literature. JRRD. 2012; 49:4 (479-496).

• Sale P, et al. Robot-assisted walking training for individuals with Parkinson’s disease: a pilot randomized

controlled trial. BMC Neurol. 2013; 13: 50.

• Sale P, Franceschini M, Mazzoleni S, Palma E, Agosti M, Posteraro F. Effects of upper limb robot-

assisted therapy on motor recovery in subacute stroke patients. Journ Neuroeng and Rehabil. 2014,

11:104.

• Talaty M, Esquenazi A. Differentiating ability in users of the rewalk powered exoskeleton. IEEE Int Conf

Rehabil Robot. Jun, 2013; 1-5.

• Tefertiller C. et al. Efficacy of rehabilitation robotics for walking training in neurological disorders: A

review. Journ Rehabil Res & Dev. 2011; 48: 387-416.

• Timmermas AA, Lemmens RJ, Monfrance M, Geers RP, Bakx W, Seelen HA. Effects of task-oriented

robot training on arm function, activity, and quality of life in chronic stroke patients: a randomized

controlled trial. J Neuroeng Rehabil. 2014 Mar 31;11:45.

• Toyo Keizai. Cyberdyne Inc.- the robot suit obtains certification in Europe. Translated from Ueraburu

Tanmatsu mo Zokuzoku Tojo- Donaru Nihon no Denshibuhin. Weekly, Sept 2013: 54-57.

• Westlake KP, Patten C. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor

recovery post-stroke. J Neuroeng Rehabil. 2009; 6:18.

• Wirz M, et al. Effectiveness of automated locomotor training in patients with chronic incomplete spinal

cord injury: a multicenter trial. Arch Phys Med Rehabil. 2005;86:4, 672-80.

• Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training; a case-series of

hemiparetic stroke survivors. Prosthet Orthot Int. 2012;36(1):113-120.

• Zeilig G, et al. Safety and tolerance of the ReWalk exoskeleton suit for ambulation by people with

complete spinal cord injury: a pilot study. Journ of Spin Cord Med. 2012; 35:2.