Spinal Stimulation and Gait Training to Improve Mobility in TBI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKessler Foundation
About this trial
The purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.
Eligibility criteria
Qualifiers
Have weakness on at least one side of my body.
No injury to my unaffected side in 6 months.
Be cleared by a physician to participate in this study.
Have had a non-penetrating TBI at least 2 years ago. A non-penetrating injury is an injury where my skull remained closed and no object entered it.
Disqualifiers
Have must have not had physical or occupational therapy or treatment for a balance disorder within 30 days prior to study enrollment. I must not participate in physical or occupation therapy throughout the duration of the study to avoid affecting the study results.
Have any medical issues that affect my unaffected side (such arthritis, fracture, etc.).
Have skin issues that would prevent me from being able to use the surface stimulation (such as a open wound or rash).
Have a pre-existing condition that may make it difficult for me to participate in exercise. (uncontrolled hypertension as described by a physician, heart disease, abnormal heart rate or rhythm, or congestive heart failure).
Trial design
Treatments tested in this trial
- Transcutaneous Spinal Cord Stimulation
- Sham
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kessler Foundation
Lead sponsor
Shirley Ryan AbilityLab
Collaborator
Source ClinicalTrials.gov