Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial

Background: Rehabilitation may attenuate the impact on mobility of patients with progressive multiple sclerosis (MS) and severe gait disabilities. Objective: In this randomized controlled trial, we compared robot-assisted gait training (RAGT) with conventional therapy (CT) in terms of gait speed, mobility, balance, fatigue and quality of life (QoL). Methods: Seventy-two patients with MS (expanded disability status scale score 6.0-7.0) were randomized to receive 12 training sessions over a 4-week period of RAGT (n = 36) or overground walking therapy (n = 36). The primary outcome was gait speed, assessed by the timed 25-foot walk test. Secondary outcome measures were walking endurance, balance, depression, fatigue and QoL. Tests were performed at baseline, intermediate, at the end of treatment and at a 3-month follow-up. Results: Sixty-six patients completed the treatments. At the end of treatment with respect to baseline, both groups significantly improved gait speed (p < 0.001) and most secondary outcomes without between-group differences. Outcome values returned to baseline at follow-up. Conclusions: RAGT was not superior to CT in improving gait speed in patients with progressive MS and severe gait disabilities where a positive, even transitory, effect of rehabilitation was observed.