Optimizing motor functions in incomplete spinal cord injury with simultaneous application of transcranial direct current stimulation and virtual reality assisted treadmill training: a study protocol for a randomized controlled trial {1a}

Incomplete spinal cord injury (iSCI) leads to significant motor impairments, affecting mobility and quality of life. Emerging rehabilitation strategies, including neuromodulation and virtual reality-assisted treadmill training, have shown potential in enhancing motor recovery among individuals with neurological conditions. However, the synergistic effects of their simultaneous application remain underexplored. This study protocol outlines a randomized controlled trial (RCT) to investigate the synergistic effects of transcranial direct current stimulation (tDCS) and virtual reality-assisted treadmill training (VRTT) on motor functions, functional independence, and quality of life of individuals with iSCI. This study is a single-blind, randomized controlled superiority trial. 52 individuals with incomplete spinal cord injury will be recruited based on inclusion criteria. They will be randomly allocated to the transcranial direct current stimulation anodal or sham group. Both groups will simultaneously receive virtual reality-assisted treadmill training and conventional therapy. The intervention will consist of 15 sessions (20 min per session) delivered over a period of 3 weeks. Participants who are unable to complete all sessions within this duration will be permitted to extend the training period by an additional week, in accordance with the intention-to-treat principle. The primary outcome measures will include muscle strength (Lower Extremity Motor Score), balance (Berg Balance Scale and Functional Reach Test), walking speed (10-m walk test), walking ability (Walking Index for Spinal Cord Injury II), and gait parameters, including step length, hip and knee joint range of motion, and vertical displacement of the center of gravity. Secondary outcome measures will include functional independence (Spinal Cord Independence Measure III) and quality of life (World Health Organization Quality of Life-BREF). The trial will provide new knowledge about the effectiveness of combined transcranial direct current stimulation with VRTT training on motor functions, functional independence, and the quality of life of individuals with iSCI. Clinical Trials Registry—India, CTRI/2024/11/076226, Registered on 04/11/2024.