Validation Of the Corticospinal Activation Protocol for Spinal Cord Injury Rehabilitation - A Delphi Consensus Study

Background Spinal cord injury (SCI) rehabilitation is often delivered through heterogeneous activity-based therapy and conventional physiotherapy, which rarely provide a standardized, neurophysiologically driven framework targeting corticospinal activation and related systems. A Corticospinal Activation Protocol (CAP) was therefore developed to offer a multidomain, mechanism-based approach tailored to individuals with incomplete SCI. Objective To formulate a novel CAP for incomplete SCI and evaluate its content, face, construct, and criterion (concurrent and preliminary predictive) validity through expert consensus and pilot clinical testing. Methods CAP was formulated via a comprehensive literature review, development of a multidomain conceptual framework (motor, sensory, autonomic, cognitive, vocational), and stakeholder consultation with individuals with SCI and clinicians. Content and face validity were established using a Delphi consensus process with a multidisciplinary expert panel rating item relevance, clarity, and essentiality and providing qualitative feedback. Construct validity was examined by correlating CAP domain scores with established neurophysiological and clinical measures (e.g. motor and somatosensory evoked potentials, autonomic function scales, ASIA lower-limb scores, WISCI-II, SCIM-III). Criterion validity was explored in a pilot study including two small groups of individuals with traumatic, incomplete thoracolumbar SCI, comparing CAP with activity-based therapy plus conventional physiotherapy over a 30-day intervention. Results Experts demonstrated near-perfect agreement on CAP item relevance and essentiality, indicating strong content validity, and qualitatively endorsed the protocol as relevant, comprehensive, and aligned with neuroplasticity-driven, functional rehabilitation. CAP domain scores showed moderate-to-strong convergent correlations with corresponding neurophysiological and functional reference measures, supporting construct validity. In the pilot study, participants receiving CAP exhibited greater improvements across electrophysiological indices, locomotor capacity, functional independence, and autonomic function than those receiving standard therapy, providing preliminary evidence of concurrent and predictive criterion validity. Conclusion The Corticospinal Activation Protocol is a theoretically grounded, stakeholder-informed, and psychometrically supported framework for rehabilitation in incomplete SCI. CAP addresses important limitations of non-standardized activity-based and conventional physiotherapy and offers a structured platform for standardized clinical implementation and future multicentre trials.