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Exosuit

Ankle Exosuit Training for Stroke Rehabilitation

N/A

Waitlist Available

Research Sponsored by Arun Jayaraman, PT, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)

Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)

Must not have

Significant paretic ankle contractures (plantarflexion > 5°)

Uncontrolled or untreated hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline day 1-3, midpoint at week 6, post-intervention at week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new technology, called an exosuit, which helps people walk. The study will look at how well the exosuit works, and how different types of training with the exosuit affect people's ability to walk.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort at the device interface sites on the body or muscle fatigue due to new walking patterns encouraged by the exosuit.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can move my ankle up to a right angle without bending my knee.

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I am between 18 and 80 years old.

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I have noticeable difficulty walking.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ankle is stiff and cannot move properly.

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My high blood pressure is not under control or treated.

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

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I have experienced unexplained dizziness in the past 6 months.

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I currently have an untreated deep vein thrombosis.

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I have a history of serious artery problems in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline day 1-3, midpoint at week 6, post-intervention at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline day 1-3, midpoint at week 6, post-intervention at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline day 1-3, midpoint at week 6, post-intervention at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 10 Meter Walk Test from baseline gait speed

Secondary study objectives

Change in 6 Minute Walk Test in distance from baseline

Functional Gait Assessment (FGA)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ReWalk Soft ExosuitExperimental Treatment2 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.

0 / 10Eligibility criteria met