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 range18 Years – 65 Years

SexALL

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.

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