INDividualised EXercise for Kneecap Dislocations

NCT03798483 | Completed Results

• 2 other identifiers: MRes/18-19/04/2251913
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Patella Dislocation; Patella Dislocation Recurrent

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• Acceptability of Outcome Data Collection

  12 weeks

• Number of Treatment Related Adverse Events Experienced by Participants

  Through 12 weeks after first physiotherapy session

• Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria

  Baseline

• Tegner Activity Scale Questionnaire

  12 weeks

• Lyhsolm Knee Scoring Scale Questionnaire

  12 Weeks

Study Arms (1)

Individualized exercise

EXPERIMENTAL

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

Other: Individualised exercise

Interventions

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.

Individualized exercise

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• City, University of London: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34749823 DERIVED

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Limitations and Caveats

This study was conducted at one centre and the sample size was small. Therefore, further larger-scale feasibility testing is required to determine if a full-scale randomised controlled trial comparing physiotherapy treatments for patients after acute patellar dislocation is viable

Results Point of Contact

• Title: Colin Forde
• Organization: Oxford University hospital foundation trust

Colin.Forde@ouh.nhs.uk

+441865221540

Study Officials

• Mark Haddad, PhD

  City, University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: January 10, 2019
• Study Start: January 24, 2019
• Primary Completion: October 8, 2019
• Study Completion: October 15, 2019
• Last Updated: February 1, 2021
• Results First Posted: February 1, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)