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INDividualised EXercise for Kneecap Dislocations (INDEX-KD)

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ClinicalTrials.gov Identifier: NCT03798483
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
City, University of London

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.

Condition or disease Intervention/treatment Phase
Patella Dislocation Patella Dislocation Recurrent Other: Individualised exercise Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Eligibility rate [Percentage of participants with a diagnosis of lateral patellar dislocation, screened for eligibility, who satisfy the eligibility criteria] [ Time Frame: Through study completion, anticipated 36 weeks ]
    Percentage of participants with a diagnosis of lateral patellar dislocation, screened for eligibility, who satisfy the eligibility criteria

  2. Recruitment rate [Percentage of eligible participants who consent to participate in the study] [ Time Frame: Through study completion, anticipated 36 weeks ]
    Percentage of eligible participants who consent to participate in the study

  3. Attrition [percentage attrition rate] [ Time Frame: 12 weeks ]
    Percentage (0-100%) of participants enrolled in the study who fail to complete 12 weeks follow-up.

  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 and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,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 [Percentage of scheduled physiotherapy sessions attended] [ Time Frame: 12 weeks ]
    Percentage (0-100%) of scheduled physiotherapy sessions attended

  6. Adherence [Percentage of prescribed home exercise sessions completed by participants] [ Time Frame: 12 weeks ]
    Participant self-reported percentage (0-100%) of prescribed home of prescribed home exercise sessions completed


Secondary Outcome Measures :
  1. Acceptability of outcome data collection [Percentage completion rates of patient reported outcome measures] [ Time Frame: 12 weeks ]
    Completion rates of patient reported outcome measures

  2. Number of treatment related adverse events [ Time Frame: 12 weeks ]
    The number and type of treatment related adverse events will be recorded. This will be recorded form 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. It also assess participant's self-reported health using a visual analogue scale from 0 (worst health you can imagine) - 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. Scores will be combined to give an index score, with higher scores indicating higher quality of life

  7. Assess delivery of the intervention [Duration from injury to commencing physiotherapy] [ Time Frame: 12 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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798483


Contacts
Contact: Colin Forde, BSc +441865221540 Colin.Forde@ouh.nhs.uk
Contact: Mark Haddad, PhD +4402070403521 mark.haddad.1@city.ac.uk

Sponsors and Collaborators
City, University of London
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Mark Haddad, PhD City, University of London
  Study Documents (Full-Text)

Documents provided by City, University of London:

Responsible Party: City, University of London
ClinicalTrials.gov Identifier: NCT03798483     History of Changes
Other Study ID Numbers: MRes/18-19/04/2
251913 ( Other Identifier: Health Research Authority - IRAS ID )
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Joint Dislocations
Patellar Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries