Effectiveness of supervised versus self-directed rehabilitation for adults aged 50 years and over with ankle fractures: protocol for the AFTER trial.
Journal
Bone & joint open
ISSN: 2633-1462
Titre abrégé: Bone Jt Open
Pays: England
ID NLM: 101770336
Informations de publication
Date de publication:
20 Jun 2024
20 Jun 2024
Historique:
medline:
20
6
2024
pubmed:
20
6
2024
entrez:
20
6
2024
Statut:
epublish
Résumé
Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures. This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation. This study will assess whether supervised rehabilitation is more effective than self-directed rehabilitation for adults aged 50 years and older after ankle fracture. The results will provide evidence to guide clinical practice. At the time of submission, the trial is currently completing recruitment, and follow-up will be completed in 2024.
Identifiants
pubmed: 38898823
doi: 10.1302/2633-1462.56.BJO-2023-0183
pii: BJO-2023-0183
doi:
Types de publication
Journal Article
Langues
eng
Pagination
499-513Subventions
Organisme : National Institute for Health and Care Research
Informations de copyright
© 2024 Keene et al.
Déclaration de conflit d'intérêts
J. Achten and M. L. Costa disclose that their employer, the University of Oxford receives, research grant funding from NIHR and Wellcome for research into musculoskeletal trauma, and R. J. Grant discloses honoraria for the AFTER trial were paid in line with INVOLVE guidelines by Oxford University. D. Appelbe reports National Institute for Health and Care Research (NIHR)/Health Technology Assessment (HTA) institutional funding. C. Forde declares being funded by the NIHR (NIHR301759) to complete a three-year Doctoral Fellowship for a separate programme of work. D. Keene declares being supported by the NIHR Exeter Biomedical Research Centre, being lead applicant on the AFTER trial, along with E. Tutton, funded by the NIHR Research for Patient Benefit programme (ref. NIHR201950), and also being co-applicant on FAME trial, funded by the NIHR HTA Programme (ref. NIHR127273), and being a committee member for the Association of Trauma and Orthopaedic Chartered Physiotherapists and the Fragility Fracture Network UK.
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