| Title: |
Specialist physiotherapy for functional motor disorder in England and Scotland (Physio4FMD): a pragmatic, multicentre, phase 3 randomised controlled trial |
| Authors: |
Nielsen, G.; Stone, J.; Lee, T.C.; Goldstein, L.H.; Marston, L.; Hunter, R.M.; Carson, A.; Holt, K.; Marsden, J.; Le Novere, M.; Nazareth, I.; Noble, H.; Reuber, M.; Strudwick, A.-M.; Santana Suarez, B.; Edwards, M.J.; Beaves, E.; Breen, D.; Burness, C.; Caddy, S.; Callaghan, H.; Carberry, A.; Chetham, L.; Clyne, A.; Cobb, S.; Coebergh, J.; Cook, L.; Cookson, P.; Cooper, P.; Diamond, C.; Drake, L.; Dunn, V.; Gardiner, P.; Gilbertson, T.; Golder, D.; Gregory, R.; Harbinson, H.; Higgins, R.; Hoeritzauer, I.; Irvine, L.; Isaacs, J.; Jay, E.; Kearney, D.; Khan, U.; Magro, J.; Mallam, E.; Harle, E.; Massey, L.; McRae, S.; Misra, S.; Mitchell, S.; Moss, C.; Mountain, E.; Murray, S.; Newby, R.; Novak, M.; Ross, A.; Rutherford, A.; Sare, G.; Sears, R.; Sedley, W.; Singhal, S.; Stanton, B.; Stone, C.; Szeto, G.; Tarr, L.; Teodoro, T.; Teweleit, V.; Walsh, M.; Warman, R.; Yogarajah, M. |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2024 |
| Collection: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| Description: |
Background: Functional motor disorder—the motor variant of functional neurological disorder—is a disabling condition that is commonly associated with poor health outcomes. Pathophysiological models have inspired new treatment approaches such as specialist physiotherapy, although evidence from large randomised controlled trials is absent. We aimed to assess the clinical effectiveness of a specialist physiotherapy intervention for functional motor disorder compared with treatment as usual. Methods: In this pragmatic, multicentre, phase 3 randomised controlled trial at 11 hospitals in England and Scotland, adults with a clinically definite diagnosis of functional motor disorder, diagnosed by a neurologist, were included. Participants were randomly assigned (1:1, stratified by site) using a remote web-based application to either specialist physiotherapy (a protocolised intervention of nine sessions plus follow-up) or treatment as usual (referral to local community neurological physiotherapy). Individuals working on data collection and analysis were masked to treatment allocation. The primary outcome was the physical functioning domain of the 36-item short form health questionnaire (SF36) at 12 months after randomisation. The primary analysis followed a modified intention-to-treat principle, using a complete case approach; participants who were unable to receive their randomised treatment due to the suspension of health-care services during the COVID-19 pandemic were excluded from the primary analysis. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN56136713, and is completed. Findings: Recruitment occurred between Oct 19, 2018, and March 11, 2020, pausing during the COVID-19 lockdown, and resuming from Aug 3, 2021, to Jan 31, 2022. Of 355 participants who were enrolled, 179 were randomly assigned to specialist physiotherapy and 176 to treatment as usual. 89 participants were excluded from the primary analysis due to COVID-19 interruption to treatment (27 were ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
1474-4422 |
| Relation: |
https://eprints.whiterose.ac.uk/id/eprint/215241/7/5.%20Manuscript%20file_shame%20and%20seizures_revised_EP.pdf; Nielsen, G. orcid.org/0000-0001-6053-5670 , Stone, J. orcid.org/0000-0001-9829-8092 , Lee, T.C. orcid.org/0009-0009-0917-860X et al. (68 more authors) (2024) Specialist physiotherapy for functional motor disorder in England and Scotland (Physio4FMD): a pragmatic, multicentre, phase 3 randomised controlled trial. The Lancet Neurology, 23 (7). pp. 675-686. ISSN: 1474-4422 |
| Availability: |
https://eprints.whiterose.ac.uk/id/eprint/215241/; https://eprints.whiterose.ac.uk/id/eprint/215241/7/5.%20Manuscript%20file_shame%20and%20seizures_revised_EP.pdf |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.B8A7183C |
| Database: |
BASE |