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Evaluation of a home-based physiotherapy programme for those with moderate to severe multiple sclerosis: a randomized controlled pilot study [with consumer summary]
Miller L, Paul L, Mattison P, McFadyen A
Clinical Rehabilitation 2011 Aug;25(8):720-730
clinical trial
7/10 [Eligibility criteria: Yes; 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: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To investigate the effect of an eight-week home-based physiotherapy programme in reducing physical impairment, disability and psychological distress for people with moderate to severe multiple sclerosis (MS). DESIGN: Pilot randomized controlled trial. SETTING: Community; subjects' homes. SUBJECTS: Thirty people moderately to severely affected by MS (Extended Disability Status Score, EDSS, 6.5 to 8) were randomized to an intervention or control group. INTERVENTION: The intervention group received twice weekly, home-based physiotherapy for eight weeks and the control group received usual care. MAIN MEASURES: The following outcome measures were recorded at baseline, post-intervention (week 8) and at follow-up (week 16). Primary outcome measure; Multiple Sclerosis Impact Scale (MSIS29) and secondary outcome measures assessed physical impairment, MS symptoms, quality of life, mood, and disability. RESULTS: Although the group x time interaction failed to reach statistical significance with MSIS29 (p = 0.925), MS-related symptom checklist (MS-RS) (p = 0.627) and for lower limb strength, right knee extension (p = 0.375) and right knee flexion (p = 0.794), there is more evidence of altered levels in the treatment group than in the control group. CONCLUSION: A minimum of 58 subjects per group are required to achieve a power of 80% at the 5% level of significance based on the MSIS29. A larger scale study is required.

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