Blood flow restricted exercise with and without transcutaneous spinal cord stimulation via telehealth in persons with tetraplegia. A protocol for randomized clinical trial

Abstract Study design A single site randomized clinical trial; Richmond, VA, USA. Objective To determine the effect of 16 weeks of home-based blood flow restriction-enhanced neuromuscular electrical stimulation (BES) and non-invasive transcutaneous spinal cord stimulation (TSS) with mass practiced (MP) training on cervical neuroplasticity and upper extremity function in individuals with tetraplegia. The program is supported by a telehealth-based approach designed to improve adherence. Methods Forty-four adults (18–70 years) with incomplete cervical SCI (AIS B–D; injury level C8 or above) will be randomized to TSS + BES + MP or sham TSS + BES + MP for 30 weeks. All participants, accompanied by a caregiver, will complete a 4-week education and training phase (2 weeks on-site, 2 weeks via telehealth), followed by 16 weeks of telehealth-supervised home training. Baseline assessments will occur before training (BL1) and after the education phase (Phase 1, BL2). Post-intervention (P1) testing will follow 16 weeks of home-based training (Phase 2), with an additional follow-up (Fw) after an 8-week washout period to evaluate any carry-over effects (Phase 3). The first 15 months will serve as a feasibility phase without randomization; data from these participants will be included within the TSS + BES + MP group. Randomization thereafter will be conducted using a computer-generated sequence. Safety and Summary Home-based TSS application for upper extremity function is a feasible and safe strategy in persons with tetraplegia. The proposal is likely to ensure long-term compliance and adherence as well as to reduce the barriers associated with exercise interventions in persons with tetraplegia. Sponsorship National Institute on Disability, Independent Living, and Rehabilitation Research [NIDILRR]. ClinicalTrials.gov Identifier NCT05423600.