CompletedNot Applicable

Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury

United States6 participantsStarted 2025-12-10

Plain-language summary

The purpose of this study is to compare two types of wearable lower-extremity exoskeletons -a self-balancing device lower-extremity exoskeleton and a user-balancing device lower-extremity exoskeleton-to better understand their effects on the physiological responses to walking and the user experience in people with spinal cord injury.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subacute to chronic SCI (≥ 3mths post injury) * Motor-complete (ASIA Impairment Scale classification A/B) * Injury level T3-T11 * Age 18-70 yrs * Height between 5'1" and 6'1" * Weight \<200 lbs (90kg) * Seated hip width \< 42cm * Standing tolerance \> 15mins * Have sufficient upper limb strength to use a platform rolling walker, rolling walker, or forearm crutches * Currently medically cleared and enrolled in the Shepherd Center Beyond Therapy program * Medically cleared for weight-bearing activities * Able to follow directions to safely participate in assessments Exclusion Criteria: * Existing skin lesions or wounds * Hip or knee contracture \> 10 degrees or ankle contracture \> 5 degrees * Severe or uncontrolled spasticity * Non-healing fractures * Uncontrolled autonomic dysreflexia * Heart or peripheral vascular condition * Pregnancy * Active heterotopic ossification * Active deep vein thrombosis * Cognitive deficits that make it difficult for participants to follow verbal instructions or making it unsafe to participate in assessments. * Any reason the principal investigator feels the potential participant may not be safe to participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

10 meter walk test (10MWT)

Timeframe: 1 year

6 minute walk test (6MWT)

Timeframe: 1 year

Trial details

NCT IDNCT07128901

SponsorGeorgia Institute of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-19

View on ClinicalTrials.gov More Spinal Cord Injuries trials