Neuromodulation of Ankle Muscles in Persons With SCI

Stopped early · Not applicable

Conditions studied: Spinal Cord Injuries, Spastic Gait, Foot Drop

In brief

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.

Key facts

Study ID

NCT04238013

Run by

Shepherd Center, Atlanta GA

People needed

1

Starts

2021-07-06

Expected to finish

2021-07-09

Last updated by the study team

2022-06-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 may exacerbate spasticity resulting in inability to identify the influence of the treatment

Where it is running

• Shepherd Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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