Low intensity interval robot-assisted gait training improves mobility in people with progressive multiple sclerosis: the PROGR-EX randomized controlled trial

摘要

BACKGROUND: Robot-assisted gait training (RAGT) is an effective strategy for rehabilitation of people with MS (PwMS) and severe gait impairment, but the optimal training parameters remain undefined. The use in continuous mode may impose high internal load and physiological stress, potentially limiting its wide applicability. OBJECTIVE: To evaluate whether a low-intensity RAGT at progressively increasing intensity (LowRAGT) improves walking function more than continuous RAGT or self-paced overground gait training (OGT). METHODS: We conducted a three-group parallel-assignment pilot, double-blinded, randomized control trial in which 24 PwMS were allocated to either LowRAGT or RAGT or OGT group, after receiving two hours of conventional rehabilitative programme. The primary outcome was gait speed assessed with the Timed 25-Foot Walk test before and after the treatment and at three-month follow-up. Secondary outcomes were mobility, endurance, balance, and patient-reported outcome measures (PROMs). RESULTS: Gait speed significantly improved after treatment in the LowRAGT (+31 %, p = 0.03) and OGT (+7 %, p = 0.04). No improvements were retained at the three-month follow-up. Only the LowRAGT retained the improvement in mobility, endurance and balance at the follow-up. No changes were observed in PROMs. CONCLUSIONS: A LowRAGT is effective in improving gait speed in PwMS and allows the long-term retention of mobility, endurance and balance improvements. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06381440).