Telehealth intervention combining exercise and stimulation for people with tetraplegia

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

This study is testing whether a new home-based program that combines special exercises and nerve stimulation can help people with tetraplegia improve their movement and quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Virginia Commonwealth University (Academic / other)
• Locations: 3 sites (Richmond, Virginia and 2 other locations)
• Trial ID: NCT05423600 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a home-based intervention that combines Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) in improving motor and functional abilities in individuals with chronic, incomplete tetraplegia. Participants will engage in a 30-week program that includes telehealth support, education, and practice sessions. The study aims to determine if this combined approach yields better outcomes than BES with sham TS. The intervention is designed to enhance upper extremity function and overall quality of life for those affected by cervical spinal cord injuries.

Who should consider this trial

Good fit: Ideal candidates are individuals with chronic, incomplete tetraplegia who are at least one year post spinal cord injury and have a neurologic level of C8 or above.

Not a fit: Patients with complete spinal cord injuries or those who do not have the necessary technology for telehealth participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve motor function and quality of life for patients with tetraplegia.

How similar studies have performed: Other studies have shown promise with similar telehealth and stimulation approaches, but this specific combination is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
2. Participants must have a companion that will be able to help him/her throughout the study.
3. Greater than 1-year post SCI, neurologic level of C8 or above.
4. American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
5. Visible muscle contraction response to NMES wrist extensors, bilaterally.
6. 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.
7. Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.

Exclusion Criteria:

1. Unhealed fracture in upper or lower extremities.
2. 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.
3. High resting blood pressure greater than 140/80 mmHg.
4. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
5. 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.
6. Implanted pacemakers and/or implanted defibrillator devices.
7. 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.
8. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
9. Other exclusion criteria at the discretion of the medical team may include:

   1. Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
   2. Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
   3. Unresolved deep vein thrombosis.
   4. Psychiatric or cognitive impairments that preclude adherence to the intervention.
   5. Known cardiac pathology that precludes safe participation.
   6. Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
   7. Presence of pressure sores stage three or greater.
   8. Presence of a symptomatic urinary tract infection.
   9. Severe spasticity as assessed by the Modified Ashworth Scale.
   10. Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.

Where this trial is running

Richmond, Virginia and 2 other locations

• Sheltering Arms Physical Rehabilitation Centers — Richmond, Virginia, United States (Recruiting)
• Richmond VA Medical Center — Richmond, Virginia, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Ashraf Gorgey, MPT, PhD, FACSM, FACRM — Virginia Commonwealth University
• Study coordinator: Ashraf Gorgey, MPT, PhD, FACSM, FACRM

Conditions Tetraplegia/Tetraparesis; Spinal Cord Injury