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.
Kneecap
Non-operative
Non-surgical
Paediatric
Patellar dislocation
Patellar instability
Patellofemoral joint dislocation
Physical therapy
Physiotherapy
Young people
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
10 Jul 2023
10 Jul 2023
Historique:
received:
23
03
2023
accepted:
20
06
2023
medline:
11
7
2023
pubmed:
11
7
2023
entrez:
10
7
2023
Statut:
epublish
Résumé
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. 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. 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. ISRCTN registry ISRCTN14235231 . Registered on 09 August 2022.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ISRCTN registry ISRCTN14235231 . Registered on 09 August 2022.
Identifiants
pubmed: 37430340
doi: 10.1186/s40814-023-01349-4
pii: 10.1186/s40814-023-01349-4
pmc: PMC10332065
doi:
Types de publication
Journal Article
Langues
eng
Pagination
119Subventions
Organisme : NIHR Doctoral Fellowship
ID : NIHR301759
Informations de copyright
© 2023. The Author(s).
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