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Web-based physiotherapy for people affected by multiple sclerosis: a single blind, randomized controlled feasibility study [with consumer summary] |
Paul L, Renfrew L, Freeman J, Murray H, Weller B, Mattison P, McConnachie A, Heggie R, Wu O, Coulter EH |
Clinical Rehabilitation 2019 Mar;33(3):473-484 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; 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* |
OBJECTIVE: To examine the feasibility of a trial to evaluate web-based physiotherapy compared to a standard home exercise programme in people with multiple sclerosis. DESIGN: Multi-centre, randomized controlled, feasibility study. SETTING: Three multiple sclerosis out-patient centres. PARTICIPANTS: A total of 90 people with multiple sclerosis (Expanded Disability Status Scale 4 to 6.5). INTERVENTIONS: Participants were randomized to a six-month individualized, home exercise programme delivered via web-based physiotherapy (n = 45; intervention) or a sheet of exercises (n = 45; active comparator). OUTCOME MEASURES: Outcome measures (0, three, six and nine months) included adherence, two-minute walk test, 25 foot walk, Berg Balance Scale, physical activity and healthcare resource use. Interviews were undertaken with 24 participants and 3 physiotherapists. RESULTS: Almost 25% of people approached agreed to take part. No intervention-related adverse events were recorded. Adherence was 40% to 63% and 53% to 71% in the intervention and comparator groups. There was no difference in the two-minute walk test between groups at baseline (intervention 80.4 (33.91) m, comparator 70.6 (31.20) m) and no change over time (at six-month intervention 81.6 (32.75) m, comparator 74.8 (36.16) m. There were no significant changes over time in other outcome measures except the EuroQol-5 Dimension at six months which decreased in the active comparator group. For a difference of 8 (17.4) m in two-minute walk test between groups, 76 participants/group would be required (80% power, p > 0.05) for a future randomized controlled trial. CONCLUSION: No changes were found in the majority of outcome measures over time. This study was acceptable and feasible by participants and physiotherapists. An adequately powered study needs 160 participants.
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