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Completed

NCT Number: NCT03798483

INDividualised EXercise for Kneecap Dislocations

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.

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Key information

Conditions

Patella Dislocation Joint Diseases Joint Dislocations Knee Injuries Leg Injuries Musculoskeletal Diseases Patella Dislocation Recurrent Patellar Dislocation Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualised exercise

Other

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.

Primary outcomes

  1. Eligibility Rate

    Time frame: 15 weeks

    Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria

  2. Recruitment Rate

    Time frame: 15 weeks

    Percentage of eligible participants who consented to participate in the study

  3. Attrition

    Time frame: 12 weeks

    Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data

  4. Acceptability [Participant Satisfaction]: Questionnaire

    Time frame: 12 weeks

    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.

  5. Adherence

    Time frame: 12 weeks

    Percentage (0-100%) of scheduled physiotherapy sessions attended

  6. Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]

    Time frame: 12 weeks

    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)

Secondary outcomes

  1. Acceptability of Outcome Data Collection

    Time frame: 12 weeks

    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

  2. Number of Treatment Related Adverse Events Experienced by Participants

    Time frame: Through 12 weeks after first physiotherapy session

    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.

  3. Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria

    Time frame: Baseline

    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

  4. Tegner Activity Scale Questionnaire

    Time frame: 12 weeks

    This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.

  5. Lyhsolm Knee Scoring Scale Questionnaire

    Time frame: 12 Weeks

    It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.

  6. Quality of Life Using the EQ-5D-5L Questionnaire

    Time frame: 12 weeks

    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.

  7. Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]

    Time frame: From date of injury until date of the first physiotherapy session, assessed up to 6 weeks

    Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention

  8. Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]

    Time frame: 12 weeks

    Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants

  9. Assess Delivery of the Intervention [Duration of Intervention]

    Time frame: 12 weeks

    Treatment logs will be analysed to assess the duration (days) of the study intervention

  10. Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]

    Time frame: 12 weeks

    Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants

  11. Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]

    Time frame: 12 weeks

    Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants

  12. Assess Delivery of the Intervention [Initial Injury Management]

    Time frame: From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks

    Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

  • Oxford University Hospitals NHS Trust

Registry information

Official study title

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

Acronym: INDEX-KD

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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