Concurrent Validity of a Novel Corticospinal Activation Protocol for Individuals with Spinal Cord Injury: A Pilot Randomized Controlled Trial

<title>Abstract</title> <p> <bold>Study Design:</bold> Two-arm, parallel-group, randomized pilot trial. <bold>Objectives:</bold> To establish the concurrent validity of a novel Corticospinal Activation Protocol (CAP) by comparing motor, sensory, functional, autonomic, and neurophysiological outcomes against conventional rehabilitation in individuals with traumatic spinal cord injury (SCI). <bold>Setting: Neuroots, Patiala (</bold> Tertiary rehabilitation centre,Patiala, India). <bold>Methods:</bold> Ten individuals with traumatic SCI (AIS grade B or C) were randomly allocated to an experimental group (n=5) receiving CAP or a control group (n=5) receiving conventional rehabilitation, both for 30 days. American Spinal Injury Association (ASIA) lower-limb motor, light touch, and pin-prick scores, the Walking Index for Spinal Cord Injury-II (WISCI-II), the Spinal Cord Independence Measure-III (SCIM-III), and general and sacral autonomic function scores were recorded at baseline, day 15, and day 30. Motor evoked potential (MEP) and somatosensory evoked potential (SSEP) latency and amplitude were recorded at baseline and day 30. Within-group change was analysed using one-way repeated-measures ANOVA (with pairwise comparisons) or paired t-tests; between-group differences in change scores were compared using independent-samples t-tests. <bold>Results:</bold> Both groups improved significantly within-group over 30 days on most measures. The experimental group showed significantly greater gains than the control group in ASIA lower-limb motor, light touch, and pin-prick scores, WISCI-II, SCIM-III, and general and sacral autonomic function by day 30 (all p&lt;0.05 for the day 0–30 change score). MEP latency decreased and amplitude increased, and SSEP latency decreased and amplitude increased, significantly more in the experimental group than the control group by day 30 (all p&lt;0.01), indicating enhanced corticospinal and dorsal column-medial lemniscal pathway conduction. <bold>Conclusions:</bold> Preliminary findings support the concurrent validity of the protocol, with CAP producing greater motor, sensory, functional, autonomic, and neurophysiological gains than conventional rehabilitation over 30 days in individuals with traumatic SCI. Adequately powered randomized controlled trials are warranted to confirm these findings. <bold>Sponsorship:</bold> DST-INSPIRE FELLOWSHIP </p>