Effectiveness of Robot-Assisted Versus Conventional Occupational Therapy on Changes in Upper Extremity Function After Cervical Spinal Cord Injury (Armeo X-over Trial): Study Protocol of a Randomised Crossover Trial

Robot-assisted therapy (RT) is increasingly implemented in rehabilitation, yet evidence on its effectiveness in improving upper extremity function after cervical spinal cord injury (cSCI) remains limited. Therefore, this randomised crossover study aims to investigate the effects of unilateral RT compared to conventional unilateral occupational therapy (OT) on upper extremity function in individuals with cSCI. 40 participants with traumatic or non-traumatic cSCI (16-81 days post-injury, neurological level of injury: C1-T1) will be randomised (1:1), stratified by their predicted recovery profile, to receive 6 weeks of RT (ArmeoSpring) and 6 weeks of OT in random order, each 3 × 30 min/week in addition to the clinical routine therapy. Assessments are conducted before (t₀), between (t₁) and after both intervention blocks (t₂ and t₃). The primary outcome is the Quantitative Grasping Subtest of the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP-QtG); primary analysis uses a linear mixed model to estimate the treatment effect based on change scores. Recruitment is currently ongoing. This randomised crossover study allows the collection of a comprehensive dataset to generate knowledge about treatment effectiveness, enabling future individuals with cSCI to benefit from improved and individualised therapy schedules.