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
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 f...
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| Format: | Article |
| Language: | English |
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BMC
2023-07-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-023-01349-4 |
| _version_ | 1797779044057481216 |
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| author | Colin Forde Matthew L. Costa Jonathan A. Cook Elizabeth Tutton Duncan Appelbe Marloes Franssen Rupert Barker David J. Keene |
| author_facet | Colin Forde Matthew L. Costa Jonathan A. Cook Elizabeth Tutton Duncan Appelbe Marloes Franssen Rupert Barker David J. Keene |
| author_sort | Colin Forde |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T23:25:04Z |
| format | Article |
| id | doaj.art-3f3431c1c25b4993b4eeefc053a472b3 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-03-12T23:25:04Z |
| publishDate | 2023-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-3f3431c1c25b4993b4eeefc053a472b32023-07-16T11:09:52ZengBMCPilot and Feasibility Studies2055-57842023-07-019111010.1186/s40814-023-01349-4Physiotherapy 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 dislocationColin Forde0Matthew L. Costa1Jonathan A. Cook2Elizabeth Tutton3Duncan Appelbe4Marloes Franssen5Rupert Barker6David J. Keene7Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordPatient and Public representativeExeter Medical School, University of ExeterAbstract 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.https://doi.org/10.1186/s40814-023-01349-4KneecapPatellar instabilityPatellofemoral joint dislocationPatellar dislocationPaediatricYoung people |
| spellingShingle | Colin Forde Matthew L. Costa Jonathan A. Cook Elizabeth Tutton Duncan Appelbe Marloes Franssen Rupert Barker David J. Keene 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 Pilot and Feasibility Studies Kneecap Patellar instability Patellofemoral joint dislocation Patellar dislocation Paediatric Young people |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Kneecap Patellar instability Patellofemoral joint dislocation Patellar dislocation Paediatric Young people |
| url | https://doi.org/10.1186/s40814-023-01349-4 |
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