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

Locations

3
Richmond VA Medical Center23249, RichmondVirginia, United States
Sheltering Arms Physical Rehabilitation Centers23226, RichmondVirginia, United States
Virginia Commonwealth University23298, RichmondVirginia, United States

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

ACL Administration for Community Living

Collaborator