Ankle Exosuit Training for Stroke Rehabilitation

Overseen By Lori L McGee, OT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arun Jayaraman, PT, PhD

Disqualifiers: Neglect, Hemianopia, DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new ankle exosuit designed to help stroke survivors improve their walking ability. The research aims to assess how this exosuit can enhance walking speed, distance, and overall movement quality. Participants will undergo training sessions to determine the optimal way the exosuit can support their walking. This trial suits individuals who had a stroke at least six months ago, have difficulty walking, and can walk for at least two minutes without assistance. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility for stroke survivors.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this exosuit is safe for stroke rehabilitation?

Research has shown that the ReWalk ReStore™ soft exosuit is safe and reliable when used with a trained physical therapist. Studies have found that this exosuit improves walking in people after a stroke. No serious side effects have been reported, indicating it is well-tolerated. The exosuit aids foot movement during walking, enhancing walking patterns. It appears to be a promising and safe option for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ankle Exosuit Training for stroke rehabilitation because it offers a cutting-edge approach to improving mobility. Unlike traditional therapies such as physical therapy exercises and ankle-foot orthoses, the ReWalk Soft Exosuit provides dynamic assistance to the ankle during walking. This wearable robotic device is designed to adapt to an individual's unique gait pattern, potentially accelerating recovery by optimizing movement patterns in real-time. By exploring different timing protocols, this method aims to discover the most effective way to enhance motor learning and functional recovery in stroke patients.

What evidence suggests that the Ankle Exosuit is effective for stroke rehabilitation?

Research shows that the ReWalk ReStore™ soft exosuit, used by participants in this trial, can aid stroke recovery. Studies have found that it enhances walking speed, endurance, and balance. When combined with a physical therapist, it safely and effectively improves walking abilities after a stroke. The exosuit supports the foot's upward and downward movement during walking, which can enhance gait. Evidence suggests these improvements can lead to better community walking and overall mobility for stroke survivors. ^{2 5 6 7 8}

Who Is on the Research Team?

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who had a stroke at least 6 months ago, can walk unassisted for two minutes, and have certain heart rate and blood pressure levels. It's not suitable for those with severe communication issues, specific visual impairments, recent dizziness, skin wounds where the device fits, significant artery disease or unresolved clots.

Inclusion Criteria

Your blood pressure should not be too low (lower than 90/60) or too high (higher than 170/90).

Medical clearance by a physician

I can walk by myself for 2 minutes, with or without help like a cane.

Exclusion Criteria

My ankle is stiff and cannot move properly.

My high blood pressure is not under control or treated.

I have sores or wounds where my medical device touches my skin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Training

Participants undergo an 18 session training protocol with the ReWalk Soft Exosuit to optimize timing and assess gait-restorative effects

12 weeks

18 sessions (in-person)

Follow-up

Participants are monitored for changes in gait speed, walking distance, and functional capacity post-intervention

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ankle Exosuit Training

Trial Overview

The study tests an exosuit that assists ankle movement during walking to improve gait after stroke. Participants will use it in clinical settings and daily life to see if it helps with walking speed, distance, mechanics of movement and energy use.

How Is the Trial Designed?

Group I: ReWalk Soft Exosuit Experimental Treatment 2 Interventions

During this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol.

Who Is Running the Clinical Trial?

Arun Jayaraman, PT, PhD

Lead Sponsor

Trials

2

Recruited

560+

U.S. Department of Education

Collaborator

Trials

87

Recruited

54,500+

Published Research Related to This Trial

Post-stroke individuals showed significant improvements in knee flexion and walking ability after just 2 weeks of training with an exoskeleton suit.

The use of the exoskeleton suit demonstrates potential as an effective rehabilitation tool for enhancing mobility in individuals recovering from a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief exosuit use improves post-stroke gait. Yashinski, M.[2023]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

A study involving 12 participants with acute/sub-acute spinal cord injuries showed that using powered exoskeletons for locomotor training is generally safe, although symptomatic hypotension was the most common adverse event reported.

The feasibility of using exoskeletons was demonstrated, with 54% protocol compliance and 58% of participants achieving at least minimal assistance during walking sessions, indicating potential for effective rehabilitation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. Delgado, AD., Escalon, MX., Bryce, TN., et al.[2021]

The study involving 46 subacute stroke patients demonstrated that overground exoskeleton-assisted gait training (OEAGT) significantly improved clinical and gait outcomes, with many patients regaining the ability to walk after treatment.

Patients reported a positive acceptance of the OEAGT, indicating its potential as an innovative rehabilitation strategy, although further randomized studies with larger samples are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Goffredo, M., Guanziroli, E., Pournajaf, S., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7301475/

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When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait ...

2.

golifeward.com

golifeward.com/products/restore-exo-suit/

ReStore™ Soft Exo-Suit For Stroke Rehabilitation

Proven therapeutic benefits, including improved walking speed, endurance, training intensity, and propulsion symmetry. ... Awad et al. “The ReWalk ReStore™ soft ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10478336/

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The goal of this review is to determine the efficacy of the SRE, and the ways it affects the biomechanical, functional, and clinical outcomes of ...

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jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-022-01034-2

Soft robotic exosuit augmented high intensity gait training on ...

The main clinical outcomes of the intervention were improving walking speed and endurance as they are the primary walking goals of the physical ...

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mdpi.com

mdpi.com/2218-6581/13/3/44

Investigation of the Effectiveness of the Robotic ReStore ...

Our objective was to determine the effect of employing a robotic soft exoskeleton in therapy on the development of the early mobilization, gait, and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32552775/

The ReWalk ReStore™ soft robotic exosuit: a multi-site ...

Conclusions: When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post- ...

7.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-020-00702-5

The ReWalk ReStore™ soft robotic exosuit: a multi-site ...

When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait ...

8.

rewalk.com

rewalk.com/wp-content/uploads/2020/11/CLN0031-REV.01-ReStore-Clinical-research-summary_.pdf

Exo-Suit Published Research Summary ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ...

Soft Robotic Exosuits for Targeted Gait Rehabilitation After Stroke ... A soft robotic exosuit assisting the paretic ankle in patients post-stroke: Effect on.