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Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): a randomized controlled trial
Straudi S, Manfredini F, Lamberti N, Martinuzzi C, Maietti E, Basaglia N
Multiple Sclerosis Journal 2019 Mar 4:Epub ahead of print
clinical trial
8/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Rehabilitation may attenuate the impact on mobility of patients with progressive multiple sclerosis (MS) and severe gait disabilities. OBJECTIVE(S): 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). METHOD(S): Seventy-two patients with MS (expanded disability status scale score 6.0 to 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. RESULT(S): 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. CONCLUSION(S): 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.

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