Clinical trial NCT03798483: INDividualised EXercise for Kneecap Dislocations
Official title: Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patella Dislocation
Patella Dislocation Recurrent
Lead sponsor: City, University of London
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2019-01-10
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a feasibility study. It will assess areas of uncertainty relating to the implementation of an individualised exercise programme for patients with a recent kneecap dislocation. This will help determine if a future larger study is feasible, and inform the design and conduct of future research that would aim to optimise outcomes after a kneecap dislocation.

Detailed description: The investigators aim to recruit 15 adult participants with a recent, first-time or recurrent kneecap dislocation, from an acute hospital. Participants will receive up to 6 physiotherapy sessions over 3 months. The investigator's exercise programme aims to improve leg muscle strength and facilitate a return to the participant's usual activities. This may include activities such as hopping and changing direction which differentiates it from other programmes. Participants will be required to perform the exercise programme 3 times a week independently. Strategies to increase adherence to the exercise programme will also be used. This study is part of a Masters in Clinical Research funded by the National Institute for Health Research

Eligibility criteria: Inclusion Criteria:

* First time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team.

Exclusion Criteria:

* Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention
* \> 4 weeks from injury to presentation to acute care (ED or trauma services)
* Unable to give written informed consent
* Previous surgery on the affected knee
* Presence of fracture on plain radiograph including osteochondral fractures
* Medial patellar dislocation
* Considered inappropriate for referral to physiotherapy (by member of trauma and orthopaedic team assessing the patient)
* History of severe neuromuscular or congenital disorders
* Patients referred for orthopaedic opinion who are subsequently listed for surgery prior to completion of the study intervention
* Unable to understand written or spoken English
* Unable to attend physiotherapy sessions at the John Radcliffe trauma outpatient physiotherapy department

Primary outcomes:
measure: Eligibility Rate
timeFrame: 15 weeks
measure: Recruitment Rate
timeFrame: 15 weeks
measure: Attrition
timeFrame: 12 weeks
measure: Acceptability [Participant Satisfaction]: Questionnaire
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
measure: Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability of Outcome Data Collection
timeFrame: 12 weeks
measure: Number of Treatment Related Adverse Events Experienced by Participants
timeFrame: Through 12 weeks after first physiotherapy session
measure: Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria
timeFrame: Baseline
measure: Tegner Activity Scale Questionnaire
timeFrame: 12 weeks
measure: Lyhsolm Knee Scoring Scale Questionnaire
timeFrame: 12 Weeks
measure: Quality of Life Using the EQ-5D-5L Questionnaire
timeFrame: 12 weeks
measure: Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]
timeFrame: From date of injury until date of the first physiotherapy session, assessed up to 6 weeks
measure: Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]
timeFrame: 12 weeks
measure: Assess Delivery of the Intervention [Duration of Intervention]
timeFrame: 12 weeks
measure: Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]
timeFrame: 12 weeks
measure: Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]
timeFrame: 12 weeks
measure: Assess Delivery of the Intervention [Initial Injury Management]
timeFrame: From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: City, University of London
name: Mark Haddad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forde C, Haddad M, Hirani SP, Keene DJ. Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study. Pilot Feasibility Stud. 2021 Nov 8;7(1):197. doi: 10.1186/s40814-021-00932-x.