Combined activity-based therapy and transcutaneous spinal cord stimulation as an intensification and supplemental approach for upper limb sensorimotor recovery: a randomised controlled trial protocol for in-patients with subacute spinal cord injury.

Abstract

Activity-based therapy (ABT) delivers intensive, repetitive sensorimotor stimulation to enhance neuroplasticity after spinal cord injury. ABT has demonstrated synergistic benefits with cervical transcutaneous spinal cord stimulation (tSCS) for motor recovery particularly in individuals with chronic cervical spinal cord injury. However, its efficacy in subacute cases remains an emerging area of research. Accordingly, this study aims to determine the efficacy of an adjunctive ABT paired with cervical tSCS compared with ABT alone on upper limb function in people with cervical spinal cord injury receiving in-patient rehabilitation. This study is a single-centre, double-blind, two-arm randomised controlled trial. We will enrol 40 individuals with cervical spinal cord injury receiving in-patient rehabilitation (20/group). Participants will be randomly assigned to an intervention group (ABT+tSCS) or a control group (dose-matched ABT+sham stimulation). Both groups will receive 45 min of ABT+active or sham tSCS in addition to usual care for 20 sessions, 3 times per week. The primary outcome measures will be the Upper Extremity Motor Score of the International Standards for Neurological Classification of Spinal Cord Injury. Secondary measures will include clinical measures of upper limb impairments and activity limitations and neurophysiological measures (transspinal, motor and somatosensory-evoked potentials). All measures will be taken pre-intervention, post-intervention and at a 1-month follow-up. This study was approved by the Research Ethics Committee en réadaptation et en déficience physique of Santé Québec Centre-Sud-de-l'Île-de-Montréal - Universitaire (MP-2024-2080). All procedures will be conducted in accordance with the principles of the Declaration of Helsinki. NCT07361627.