Development and validation of a practical documentation of inpatient rehabilitation goals, therapy content and outcomes for improving mobility in people with multiple sclerosis in Austria: A multicentre single-arm pragmatic clinical trial

BACKGROUND: Improved understanding of effective therapeutic interventions (TI) is required to optimise mobility outcomes in people with multiple sclerosis (pwMS) undergoing multidisciplinary neurological rehabilitation (MNR). The primary objective was to explore clinically meaningful effects of active TI on mobility during inpatient MNR. Secondary objectives were to assess mobility-related goal attainment and to develop and evaluate a standardised TI documentation catalogue. METHODS: A TI catalogue and manual were developed and refined based on moderate interrater reliability from 12 video-recorded therapy sessions rated by eight clinicians. Usability was assessed by 47 physiotherapists using the System Usability Scale (SUS). Mobility outcomes included the 12-item Multiple Sclerosis Walking Scale (MSWS-12), 2-Minute Walk Test (2 MWT), Five Times Sit-to-Stand Test (5-TSTS), and Timed 25-Foot Walk. Effect sizes were calculated for individual and group-based TI. Goal attainment was measured using Goal Attainment Scaling. RESULTS: The TI catalogue showed good usability (mean SUS score 72.3). Significant improvements were observed across all mobility outcomes, with clinically meaningful changes for MSWS-12, 2MWT and 5-TSTS. Gait training variants, robot-assisted gait training, strength, task-oriented, dual-task, endurance, coordination, and balance training showed medium-to-large effect sizes. Goal achievers demonstrated significantly greater improvements in walking perception, speed, and distance than non-achievers, with no difference in sit-to-stand performance. Over 88% of 255 pwMS achieved or exceeded their therapy goals. CONCLUSIONS: The TI catalogue is a reliable and practical tool for documenting TI in routine MNR. Several interventions, particularly stair gait training, strength training, and robot-assisted gait training, were associated with clinically meaningful mobility improvements in pwMS. TRIAL REGISTRATION: The study was prospectively registered with the German Clinical Trials Register (DRKS00025216 and DRKS00030391).