RecruitingNot Applicable

Exoskeleton and Spinal Cord Stimulation for SCI

United States24 participantsStarted 2017-03-30

Plain-language summary

The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.

Who can participate

Age range

18 Years – 65 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: In order to be eligible to participate in this study a participant must: * be a non-walker with an SCI greater than 6 years post injury; * have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam; * be between the ages of 18-65 years old; * have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10; * be wheelchair reliant 100% of the time; * have knee bone mineral density great than .5755gm/cm2 as determined by study staff; Exclusion Criteria: * have a history of broken or fractured bones. * have a history of bone trauma or bone disease.

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

Percentage change 6-minute walk test (6MWT)

Timeframe: Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions.

Percentage change 10 meter walk test (10MWT)

Trial details

NCT IDNCT03096197

SponsorKessler Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Gail F Forrest, PhD

973-324-3518 gforrest@kesslerfoundation.org

View on ClinicalTrials.gov More Spinal Cord Injury trials