Neuromodulation of Ankle Muscles in Persons With SCI (NCT04238013) | Clinical Trial Compass
TerminatedNot Applicable
Neuromodulation of Ankle Muscles in Persons With SCI
Stopped: Due to the ongoing COVID-19 pandemic, my recruitment progress was delayed to the point that I had to reevaluate the feasibility of continuing data collection.
United States1 participantsStarted 2021-07-06
Plain-language summary
The ability to voluntarily move the ankles is important for walking. After spinal cord injury (SCI), this ability is impaired because of changes in the communication between the brain, spinal cord, and body. Whole body vibration (WBV) is a treatment that increases voluntary muscle control and decreases uncontrollable muscle movement in people with SCI. The purpose of this study is to understand how WBV can impact ankle control and uncontrollable muscle movement.
Who can participate
Age range
18 Years – 85 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:
* Ability and willingness to consent and authorize use of Protected Health Information (PHI)
* Be between 18-85 years of age
* Be able to provide a letter of medical clearance for participation, if 70-85 years of age
* Have a SCI level of T12 of above, occurring more than 6 months ago
* Have a motor-incomplete severity classification (AIS C OR D)
* Have self-reported spasticity in at least one ankle
* Have a score of at least 2 indicating at least moderate spasticity on the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) clonus test in at least one ankle
* Have the ability to voluntarily move at least one ankle
* Must be able to stand and take at least 4 steps with or without assistive devices
Exclusion Criteria:
* Implanted metallic device in the head and/ or pacemaker
* Use of ankle-foot orthoses
* History of seizures
* History of frequent and/ or severe headaches
* Prior tendon or nerve transfer surgery
* Current pregnancy
* Inability or unwillingness to consent and Authorization for use of PHI
* Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
* Neurologic level below spinal level T12
* History of cardiovascular irregularities
* Problems with following instructions
* Orthopedic problems that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees).
* Active infection of any type, as infection ma…
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.