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

Overview

Journal Pilot Feasibility Stud

Publisher Biomed Central

Date 2023 Jul 10

PMID 37430340

Authors

Colin Forde

Matthew L Costa

Jonathan A Cook

Elizabeth Tutton

Duncan Appelbe

Marloes Franssen

Rupert Barker

David J Keene

Affiliations

Soon will be listed here.

Abstract

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 full-scale trial comparing supervised versus self-managed rehabilitation for people after acute first-time or recurrent patellar dislocation. This full-scale trial's results would provide high-quality evidence to guide rehabilitation provision for patients with this injury.

Trial Registration: ISRCTN registry ISRCTN14235231 . Registered on 09 August 2022.

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