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Exoskeleton

Exoskeleton Assistance for Post-Stroke Gait Improvement

N/A

Waitlist Available

Led By Aaron Young, PhD

Research Sponsored by Georgia Institute of Technology

Eligibility Criteria Checklist

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

Must have

Ability to sit unsupported for minimum of 30 seconds

Ability to walk without support (a rail as needed), with a walking speed of at least 0.4 m/s (limited community ambulatory speed)

Must not have

A complete spinal cord injury

History of any severe cardiovascular conditions, severe arthritis, or orthopedic problems that limit lower body movement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial combines exoskeleton technology & user feedback to improve robotic assistance for stroke survivors' gait. It tests exoskeletons in real-world contexts to measure outcomes & user perceptions, with the goal of deploying self-adaptive, adoptable exoskeletons for personalized assistance.

Who is the study for?

This trial is for chronic stroke survivors aged 18-85 who can walk at least a little bit and have been living with the condition for over six months. They should be able to sit without help, transfer from sitting to standing, handle small slopes and steps, and commit to a few hours of testing with breaks.

What is being tested?

The study tests how well different exoskeleton devices assist walking in real-world settings. Participants will try out robotic systems that support either the hip or ankle during movement, aiming to improve their gait after a stroke.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort while using the device, skin irritation where it attaches, muscle fatigue due to new movements or adjustments in gait patterns.

Eligibility Criteria

Inclusion Criteria

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

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I can sit without support for at least 30 seconds.

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I can walk on my own at a moderate pace.

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I can walk for at least 6 minutes without stopping.

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I can sit and stand without help, but using armrests is okay.

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I can walk up slight slopes and a few steps without help.

Exclusion Criteria

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

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I have a complete spinal cord injury.

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I have severe heart issues or joint problems that restrict my leg movement.

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I have a neurological disorder like Parkinson's, ALS, MS, or dementia.

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I am on kidney dialysis or have end-stage liver disease.

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I am legally blind or have severe vision problems.

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I have a pacemaker or metal implants in my head.

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I have open sores on my leg that won’t heal.

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I have had an amputation of a part of my lower limb.

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I experience seizures that my current medication cannot control.

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I have lost feeling in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

10 meter walk test (10MWT)

6-minute walk test (6MWT)

Borg Rating of Perceived Exertion (RPE)

+1 more

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: Stroke SurvivorsExperimental Treatment3 Interventions

This study will be divided into 2 sessions that will occur on 2 separate days: 1) Hip Exoskeleton session and 2) Ankle Exoskeleton session. In each session, subjects will undergo two conditions in which they complete the outcomes measures 1) while wearing the exoskeleton and 2) in a baseline condition without the exoskeleton. Order of condition and session will be randomized. Prior to the exoskeleton condition, subjects will be allowed time to acclimate to the device during a walking session on the treadmill. Subjects will complete several timed walking tests both indoors and outdoors. Measurements of energy expenditure may also be recorded along with patient reported outcomes data to assess participant perception of their performance with and without the devices.

0 / 15Eligibility criteria met