A Research Protocol to Study the Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early Vs. Late Locomotor Training

Spinal cord injury (SCI) often results in severe motor and sensory deficits, leading to significant disability. Preclinical studies and retrospective studies suggest that a critical window of enhanced neuroplasticity may exist immediately after SCI, during which therapeutic interventions could yield greater functional improvements. The impact of time interval since SCI on efficacy of rehabilitation has not been directly assessed and is the focus of this clinical trial. This study will compare the efficacy of high-intensity gait training, initiated at different time intervals post-injury, on walking performance in individuals with SCI. We hypothesize that early intervention will yield the greatest improvements in walking ability and community ambulation, compared to training initiated at 3 or 6 months after SCI, or standard of care. This randomized, multi-site clinical trial will enroll 108 participants with acute, traumatic SCI. Participants will be randomized to receive 20 h of high-intensity gait training that will be initiated either early (< 60 days post-SCI), sub-acute (3 months), chronic (6 months), or to a control group receiving standard of care. Primary outcomes include gait speed (10 m Walk Test) and walking endurance (6-Minute Walk Test). Secondary outcomes include daily step count via wearable sensors, lower extremity strength, and quality of life measures. Assessments will occur at baseline, pre/post-intervention, and at 3, 6, 9, and 12 months post-SCI. This study will provide insights into the optimal timing of rehabilitation post-SCI and could have profound effects on our approach to training individuals with SCI in the healthcare setting as well as long term recovery outcomes. Trial registration ClinicalTrials.gov NCT06176833 was completed on 12/11/2023.