INDividualised EXercise for Kneecap Dislocations

Patella Dislocation Clinical Trial

— INDEX-KD  

Official title:

Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798483
• Other study ID #: MRes/18-19/04/2
• Secondary ID: 251913
• Status: Completed
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: December 2018
• Source: City, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 15, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patella Dislocation
• Patella Dislocation Recurrent
• Patellar Dislocation

Intervention

Other:
• Individualised exercise
The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
City, University of London	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility Rate	Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria	15 weeks
Primary	Recruitment Rate	Percentage of eligible participants who consented to participate in the study	15 weeks
Primary	Attrition	Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data	12 weeks
Primary	Acceptability [Participant Satisfaction]: Questionnaire	Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.	12 weeks
Primary	Adherence	Percentage (0-100%) of scheduled physiotherapy sessions attended	12 weeks
Primary	Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]	Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)	12 weeks
Secondary	Acceptability of Outcome Data Collection	Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up	12 weeks
Secondary	Number of Treatment Related Adverse Events Experienced by Participants	The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up.	Through 12 weeks after first physiotherapy session
Secondary	Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria	Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction	Baseline
Secondary	Tegner Activity Scale Questionnaire	This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.	12 weeks
Secondary	Lyhsolm Knee Scoring Scale Questionnaire	It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.	12 Weeks
Secondary	Quality of Life Using the EQ-5D-5L Questionnaire	This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire.	12 weeks
Secondary	Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]	Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention	From date of injury until date of the first physiotherapy session, assessed up to 6 weeks
Secondary	Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]	Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants	12 weeks
Secondary	Assess Delivery of the Intervention [Duration of Intervention]	Treatment logs will be analysed to assess the duration (days) of the study intervention	12 weeks
Secondary	Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]	Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants	12 weeks
Secondary	Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]	Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants	12 weeks
Secondary	Assess Delivery of the Intervention [Initial Injury Management]	Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team	From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks