Status:
RECRUITING
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
ACL Administration for Community Living
Conditions:
Tetraplegia/Tetraparesis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 mot...
Detailed Description
Cervical spinal cord injury (cSCI) results in physical impairment and limited mobility, with the most severe cSCI necessitating wheelchair use for ambulation and impaired upper extremity function resu...
Eligibility Criteria
Inclusion
- 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
- 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.
- Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
- Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
- Other exclusion criteria at the discretion of the medical team may include:
- 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.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05423600
Start Date
June 15 2022
End Date
September 1 2026
Last Update
July 1 2025
Active Locations (3)
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1
Sheltering Arms Physical Rehabilitation Centers
Richmond, Virginia, United States, 23226
2
Richmond VA Medical Center
Richmond, Virginia, United States, 23249
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23298