BMJ Open. 2026 Mar 18;16(3):e107352. doi: 10.1136/bmjopen-2025-107352.
ABSTRACT
INTRODUCTION: This multi-centre, randomised controlled trial (RCT) investigates the effects of intensive upper limb (UL) motor training on neurophysiological and functional recovery in individuals with cervical spinal cord injury (c-SCI) during the sub-acute phase. The study aims first to assess neurophysiological adaptations in the central and peripheral nervous systems and functional changes to evaluate the impact of intensive UL motor training on recovery. Second, it determines dose dimensions and their correlation with neural and functional improvements.
METHODS AND ANALYSIS: A total of 44 individuals with c-SCI within 13 weeks post-injury will be recruited from five rehabilitation centres in Belgium and the Netherlands. They will be randomised into an intervention group, receiving six additional hours of goal-directed UL training per week for 8 weeks, or a control group receiving standard care. Primary outcomes are changes in resting motor threshold, a proxy for corticospinal tract integrity; compound muscle action potential amplitude, indicating peripheral nerve excitability and functionality; and assessments of strength, sensory function and prehension, with the primary comparison between groups at baseline and after the intervention period. Secondary outcomes cover additional neurophysiological assessments and motor function. Dose dimensions will be quantified and related to primary and secondary outcomes.
ETHICS AND DISSEMINATION: The central medical ethics committees, METC Máxima MC (NL84212.015.23) and MEC Gent (B6702023000227), as well as local ethics committees, reviewed and approved this trial. The protocol is registered (ClinicalTrials.gov; NCT06065384). The findings of this RCT will be disseminated through articles in peer-reviewed journals and at neurological rehabilitation conferences.
TRIAL REGISTRATION NUMBER: NCT06065384.
PMID:41857841 | DOI:10.1136/bmjopen-2025-107352