| Title: |
Physiotherapy Rehabilitation Post Patellar Dislocation (PRePPeD)-protocol for an external pilot randomised controlled trial and qualitative study comparing supervised versus self-managed rehabilitation for people after acute patellar dislocation |
| Authors: |
Forde, C; Costa, ML; Cook, JA; Tutton, E; Appelbe, D; Franssen, M; Barker, R; Keene, DJ |
| Publisher Information: |
BioMed Central |
| Publication Year: |
2023 |
| Collection: |
Oxford University Research Archive (ORA) |
| Description: |
Background Patellar dislocations mainly affect adolescents and young adults. After this injury, patients are usually referred to physiotherapy for exercise-based rehabilitation. Currently, limited high-quality evidence exists to guide rehabilitation practice and treatment outcomes vary. A full-scale trial comparing different rehabilitation approaches would provide high-quality evidence to inform rehabilitation practice. Whether this full-scale trial is feasible is uncertain: the only previous trial that compared exercise-based programmes in this patient population had high loss to follow-up. This study aims to assess the feasibility of conducting a future full-scale trial comparing the clinical and cost-effectiveness of two different rehabilitation approaches for people with an acute patellar dislocation. Methods Two-arm parallel external pilot randomised controlled trial and qualitative study. We aim to recruit at least 50 participants aged ≥ 14 years with an acute first-time or recurrent patellar dislocation from at least three English National Health Service hospitals. Participants will be randomised 1:1 to supervised rehabilitation (four to six, one-to-one, physiotherapy sessions of advice and prescription of tailored progressive home exercise over a maximum of 6 months) or self-managed rehabilitation (one physiotherapy session of self-management advice, exercise, and provision of self-management materials). Pilot objectives are (1) willingness to be randomised, (2) recruitment rate, (3) retention, (4) intervention adherence, and (5) intervention and follow-up method acceptability to participants assessed through one-to-one semi-structured interviews (maximum 20 participants). Follow-up data will be collected 3, 6, and 9 months after randomisation. Quantitative pilot and clinical outcomes will be numerically summarised, with 95% confidence intervals generated for the pilot outcomes using Wilson’s and exact Poisson methods as appropriate. Discussion This study will assess the feasibility of conducting a ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1186/s40814-023-01349-4 |
| Availability: |
https://doi.org/10.1186/s40814-023-01349-4; https://ora.ox.ac.uk/objects/uuid:2344f234-49ac-4132-b27e-d5b9f9383a27 |
| Rights: |
info:eu-repo/semantics/openAccess ; CC Attribution (CC BY) |
| Accession Number: |
edsbas.8D16DBFB |
| Database: |
BASE |