Epidural Stimulation and Resistance Training (REST-SCI) for Overground Locomotion After Spinal Cord Injury: Randomized Clinical Trial Protocol
Abstract
Introduction: Implanted spinal cord epidural stimulation (SCES) is an emerging neuromodulation approach that increases the excitability of the central pattern generator [CPG] and enhances tonic and rhythmic motor patterns after spinal cord injury (SCI). We determine the effects of exoskeleton-assisted walking [EAW] + epidural stimulation [ES] + resistance training [RT] on volitional motor control as a primary outcome, as well as autonomic cardiovascular profile, body composition, and bladder function compared to EAW + delayed ES + noRT in persons with motor-complete SCI AIS A and B. Methods and Analysis: Twenty male and female participants [age 18–60 years] with traumatic motor-complete SCI [2 years or more post injury], and level of injury below C5 were randomized into either EAW + ES + RT or EAW + delayed-ES + no-RT groups for more than 12 months. Baseline, post-interventions 1 and 2 were conducted six months apart. Measurements included body composition assessment using anthropometry, dual x-ray absorptiometry, and magnetic resonance imaging prior to implantation to evaluate the extent of spinal cord damage, neurophysiologic assessments to record H-reflexes, overground ambulation and peak torque for both groups, and the Walking Index for Spinal Cord Injury Scale [WISCI 2]. Metabolic profile measurements included the resting metabolic rate, fasting biomarkers of HbA1c, lipid panels, total testosterone CRP, IL-6, TNF-α, plasma IGF-I, IGFBP-3, and then a glucose tolerance…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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