INDividualised EXercise for Kneecap Dislocations (INDEX-KD)

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

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.

Study Overview

• Status: Completed
• Conditions: Patella Dislocation; Patella Dislocation Recurrent
• Intervention / Treatment: Other: Individualised exercise

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

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Individualized exercise; Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligibility Rate	Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria	15 weeks
Recruitment Rate	Percentage of eligible participants who consented to participate in the study	15 weeks
Attrition	Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data	12 weeks
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
Adherence	Percentage (0-100%) of scheduled physiotherapy sessions attended	12 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Assess Delivery of the Intervention [Duration of Intervention]	Treatment logs will be analysed to assess the duration (days) of the study intervention	12 weeks
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
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
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

Collaborators and Investigators

• Sponsor: City, University of London
• Collaborators: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Mark Haddad, PhD, City, University of London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: MRes/18-19/04/2; 251913 (Other Identifier: Health Research Authority - IRAS ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No