RECRUITING

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

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Conditions

Tetraplegia/TetraparesisSpinal Cord Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-15
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05423600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
  2. 2. Participants must have a companion that will be able to help him/her throughout the study.
  3. 3. Greater than 1-year post SCI, neurologic level of C8 or above.
  4. 4. American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
  5. 5. Visible muscle contraction response to NMES wrist extensors, bilaterally.
  6. 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. 7. Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
  1. 1. Unhealed fracture in upper or lower extremities.
  2. 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. 3. High resting blood pressure greater than 140/80 mmHg.
  4. 4. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
  5. 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. 6. Implanted pacemakers and/or implanted defibrillator devices.
  7. 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. 8. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
  9. 9. Other exclusion criteria at the discretion of the medical team may include:
  10. 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
  11. 2. Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
  12. 3. Unresolved deep vein thrombosis.
  13. 4. Psychiatric or cognitive impairments that preclude adherence to the intervention.
  14. 5. Known cardiac pathology that precludes safe participation.
  15. 6. Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
  16. 7. Presence of pressure sores stage three or greater.
  17. 8. Presence of a symptomatic urinary tract infection.
  18. 9. Severe spasticity as assessed by the Modified Ashworth Scale.
  19. 10. Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.

Contacts and Locations

Study Contact

Ashraf Gorgey, MPT, PhD, FACSM, FACRM
CONTACT
804-675-5000
Ashraf.Gorgey@va.gov
Refka Khalil
CONTACT
804-675-5000
Refka.Khalil@va.gov

Principal Investigator

Ashraf Gorgey, MPT, PhD, FACSM, FACRM
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Sheltering Arms Physical Rehabilitation Centers
Richmond, Virginia, 23226
United States
Richmond VA Medical Center
Richmond, Virginia, 23249
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Ashraf Gorgey, MPT, PhD, FACSM, FACRM, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-15
Study Completion Date2026-09

Study Record Updates

Study Start Date2022-06-15
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injury

Additional Relevant MeSH Terms

  • Tetraplegia/Tetraparesis