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 range18 Years – 85 Years

SexALL

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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…

What they're measuring

Volitional Ankle Control-Tapping Task Performance

Timeframe: Through study completion at 2 weeks

Ankle Spasticity-Ankle Clonus

Timeframe: Through study completion at 2 weeks

Trial details

NCT IDNCT04238013

SponsorShepherd Center, Atlanta GA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-09