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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.

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 data supports the effectiveness of the treatment Ankle Exosuit Training for stroke rehabilitation?

Research shows that using an ankle exosuit can improve walking ability in stroke patients by enhancing propulsion and ground clearance, which are common walking issues after a stroke. Studies also indicate that exosuits can help increase walking speed and step count, suggesting they may be a useful tool for stroke rehabilitation. ^{1 2 3 4 5}

Is Ankle Exosuit Training safe for humans?

Studies suggest that exosuits, including ankle exosuits, are generally safe for use in stroke rehabilitation. However, in a study involving spinal cord injury patients, some experienced symptomatic hypotension (low blood pressure), indicating that while generally safe, monitoring for adverse events is important. ^{1 2 3 4 6}

How does Ankle Exosuit Training differ from other stroke rehabilitation treatments?

Ankle Exosuit Training is unique because it uses a wearable robotic device to assist the paretic (weakened) ankle, improving walking mechanics and propulsion in stroke patients. Unlike traditional passive devices, the exosuit actively supports the ankle during walking, potentially enhancing gait and reducing the energy cost of walking. ^{1 2 3 7 8}

Research Team

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Design and evaluation of an independent 4-week, exosuit-assisted, post-stroke community walking program. [2023]

2. England pubmed.ncbi.nlm.nih.gov

O 089 - A soft robotic exosuit assisting the paretic ankle in patients post-stroke: Effect on muscle activation during overground walking. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. [2020]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A soft robotic exosuit improves walking in patients after stroke. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effects of a soft robotic exosuit on the quality and speed of overground walking depends on walking ability after stroke. [2023]