Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVirginia Commonwealth University

About this trial

The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.

Eligibility criteria

Qualifiers

A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.

Participants must have a companion that will be able to help him/her throughout the study.

Greater than 1-year post SCI, neurologic level of C8 or above.

American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.

Disqualifiers

Unhealed fracture in upper or lower extremities.

Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.

High resting blood pressure greater than 140/80 mmHg.

Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.

Trial design

Treatments tested in this trial

  • BES + TS
  • Experimental: BES+sham TS

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

ACL Administration for Community Living

Collaborator