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Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

RecruitingNAAges 18 Years - 85 YearsAllOhio State University
NCT05337982 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. This will include checking for certain features called biomarkers by testing participants' spinal fluid and blood and compare these features to individuals without SCI. These features will help investigators determine when to start the new training program, either right away or waiting for 3 months. The new training program uses walking downhill on a slight slope on a treadmill while muscles that are not working normally are stimulated to contract using low levels of electricity. Adding this stimulation will allow people to practice walking and other skills even though full muscle control has not recovered. This new program

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📋 Eligibility rules (as published)
INCLUSION CRITERIA: SCI participants WITHIN 1-5 MONTHS OF THEIR INJURY: * Discharged from inpatient rehabilitation; * AIS A-D at neurologic level C1-T10; * 18-85 years old. Healthy controls: * Adults 18-85 years old; * no recent major musculoskeletal injury; * no recent surgery. EXCLUSION CRITERIA: SCI participants: * Use of botox in the past 3 months that reduces skeletal muscle function; * other neurologic conditions (i.e. brain injury, stroke, HIV); * current cancer diagnosis; * active deep vein thrombosis and anti-coagulation therapy; * skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training. * pregnancy; * ventilator-dependence; * cognitive conditions that preclude providing informed consent. * Implanted medical devices that are contraindicated for electrical stimulation or MRI \*(If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.) Healthy controls: * Implanted medical devices that are contraindicated for MRI (MRI participants only); * neurologic conditions (i.e. brain injury, stroke, HIV); * current cancer diagnosis; * clotting disorders requiring anti-coagulation therapy; * inflammatory conditions like arthritis, ulcerative colitis, lupus, etc; * pregnancy; * fear of needles; * claustrophobia; * cognitive conditions that preclude providing informed consent.
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What it tests

  • Downhill Eccentric Treadmill Training with Electrical Stimulation
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Where

2 sites
The Ohio State University
Columbus, United States
University of British Columbia
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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