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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT05423600
Status
Recruiting
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Conditions

  • Tetraplegia/Tetraparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • BES + TS — PROCEDURE
    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)
  • Experimental: BES+sham TS — PROCEDURE
    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)

Study Details

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.

Key Dates

Start date
Jun 15, 2022
Status verified
Jun 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BES+TS
    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)
  • Experimental: BES+sham TS
    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)

Primary Outcome Measure

Change in hand functional activities [ Time Frame: Baseline to 20 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Richmond VA Medical CenterRichmondVirginia23249-
Sheltering Arms Physical Rehabilitation CentersRichmondVirginia23226-
Virginia Commonwealth UniversityRichmondVirginia23298-

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By research site
Richmond VA Medical Center· Richmond, VASheltering Arms Physical Rehabilitation Centers· Richmond, VAVirginia Commonwealth University· Richmond, VA

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