Back to resultsINDividualised EXercise for Kneecap Dislocations (INDEX-KD)
Primary Purpose
Patella Dislocation, Patella Dislocation Recurrent
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Individualised exercise
Sponsored by
About this trial
This is an interventional treatment trial for Patella Dislocation
Eligibility 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
Sites / Locations
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Individualized exercise
Arm Description
Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist
Outcomes
Primary Outcome Measures
Eligibility Rate
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
Recruitment Rate
Percentage of eligible participants who consented to participate in the study
Attrition
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
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.
Adherence
Percentage (0-100%) of scheduled physiotherapy sessions attended
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)
Secondary Outcome Measures
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
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.
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
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.
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.
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.
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
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
Assess Delivery of the Intervention [Duration of Intervention]
Treatment logs will be analysed to assess the duration (days) of the study intervention
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
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
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
Full Information
NCT ID
NCT03798483
First Posted
December 11, 2018
Last Updated
January 12, 2021
Sponsor
City, University of London
Collaborators
Oxford University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03798483
Brief Title
INDividualised EXercise for Kneecap Dislocations
Acronym
INDEX-KD
Official Title
Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City, University of London
Collaborators
Oxford University Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella Dislocation, Patella Dislocation Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individualized exercise
Arm Type
Experimental
Arm Description
Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist
Intervention Type
Other
Intervention Name(s)
Individualised exercise
Intervention Description
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 Measure Information:
Title
Eligibility Rate
Description
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
Time Frame
15 weeks
Title
Recruitment Rate
Description
Percentage of eligible participants who consented to participate in the study
Time Frame
15 weeks
Title
Attrition
Description
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
Time Frame
12 weeks
Title
Acceptability [Participant Satisfaction]: Questionnaire
Description
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.
Time Frame
12 weeks
Title
Adherence
Description
Percentage (0-100%) of scheduled physiotherapy sessions attended
Time Frame
12 weeks
Title
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Acceptability of Outcome Data Collection
Description
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
Time Frame
12 weeks
Title
Number of Treatment Related Adverse Events Experienced by Participants
Description
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.
Time Frame
Through 12 weeks after first physiotherapy session
Title
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria
Description
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
Time Frame
Baseline
Title
Tegner Activity Scale Questionnaire
Description
This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.
Time Frame
12 weeks
Title
Lyhsolm Knee Scoring Scale Questionnaire
Description
It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.
Time Frame
12 Weeks
Title
Quality of Life Using the EQ-5D-5L Questionnaire
Description
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.
Time Frame
12 weeks
Title
Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]
Description
Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention
Time Frame
From date of injury until date of the first physiotherapy session, assessed up to 6 weeks
Title
Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]
Description
Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants
Time Frame
12 weeks
Title
Assess Delivery of the Intervention [Duration of Intervention]
Description
Treatment logs will be analysed to assess the duration (days) of the study intervention
Time Frame
12 weeks
Title
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]
Description
Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants
Time Frame
12 weeks
Title
Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]
Description
Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants
Time Frame
12 weeks
Title
Assess Delivery of the Intervention [Initial Injury Management]
Description
Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team
Time Frame
From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Haddad, PhD
Organizational Affiliation
City, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
34749823
Citation
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.
Results Reference
derived
Learn more about this trial
INDividualised EXercise for Kneecap Dislocations
We'll reach out to this number within 24 hrs