Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Virginia Commonwealth University
44 participants
Jun 15, 2022
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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.
- Visible muscle contraction response to NMES wrist extensors, bilaterally.
- Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
- Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
Exclusion Criteria17
- 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.
- Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
- Implanted pacemakers and/or implanted defibrillator devices.
- Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
- Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
- Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
- Unresolved deep vein thrombosis.
- Psychiatric or cognitive impairments that preclude adherence to the intervention.
- Known cardiac pathology that precludes safe participation.
- Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
- Presence of pressure sores stage three or greater.
- Presence of a symptomatic urinary tract infection.
- Severe spasticity as assessed by the Modified Ashworth Scale.
- Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)
Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05423600