Lorna Paul1, Linda Renfrew2, Jennifer Freeman3, Heather Murray4, Belinda Weller5, Paul Mattison3, Alex McConnachie4, Robert Heggie6, Olivia Wu6, Elaine H Coulter1. 1. 1 School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK. 2. 2 Multiple Sclerosis Service, NHS Ayrshire & Arran, Irvine, UK. 3. 3 School of Health Professions, University of Plymouth, Plymouth, UK. 4. 4 Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK. 5. 5 Anne Rowling Regenerative Neurology Clinic, NHS Lothian, Edinburgh, UK. 6. 6 Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Abstract
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 4-6.5). 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%-63% and 53%-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.
RCT Entities:
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 4-6.5). 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%-63% and 53%-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.
Authors: William Bevens; Tracey J Weiland; Kathleen Gray; Sandra L Neate; Nupur Nag; Steve Simpson-Yap; Jeanette Reece; Maggie Yu; George A Jelinek Journal: Front Public Health Date: 2022-04-27
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