An interventional study of Individualised exercise in Patella Dislocation and Patella Dislocation Recurrent, sponsored by City, University of London. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by City, University of London · Not applicable, Interventional, and Treatment
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.
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
41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 22 interventional studies indexed under Patellar Dislocation.
Browse Patellar Dislocation studies →City, University of London is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Eligibility Rate
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
Time frame: 15 weeks
Recruitment Rate
Percentage of eligible participants who consented to participate in the study
Time frame: 15 weeks
Attrition
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
Time frame: 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.
Time frame: 12 weeks
Adherence
Percentage (0-100%) of scheduled physiotherapy sessions attended
Time frame: 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)
Time frame: 12 weeks
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Assess Delivery of the Intervention [Duration of Intervention]
Treatment logs will be analysed to assess the duration (days) of the study intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks
| Milestone | Individualized Exercise |
|---|---|
| Started | 15 |
| Returned all follow-up outcome data | 11 |
| Completed | 13 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
| Participants | Patients With a Diagnosed Lateral Patellar Dislocation |
|---|---|
| Eligibility Rate | 15 |
Percentage of eligible participants who consented to participate in the study
| Participants | Individualized Exercise |
|---|---|
| Recruitment Rate | 15 |
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
| Participants | Individualized Exercise |
|---|---|
| Attrition | 2 |
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.
| units on a scale | Participants Who Completed and Returned Follow-up Outcome Data |
|---|---|
| How satisfied are you with the effect of your physiotherapy treatment? | 0 (0 to 0) |
| How satisfied are you with your involvement in decision making about your physiotherapy treatment? | 0 (0 to 0) |
| How satisfied were you with up to six physiotherapy sessions over three months after your injury? | 0 (0 to 0) |
| How satisfied were you with the written information you were given describing the study? | 0 (0 to 0) |
| How satisfied were you with the written information you were given about your injury? | 0 (0 to 1) |
| How satisfied are you overall with the physiotherapy care you received after your injury? | 0 (0 to 0) |
| How confident are you that you can return to all your normal activities? | 0 (0 to 1) |
| How did doing your exercises fit into your weekly routine? | 1 (0 to 2) |
| How confident are you that you were doing your exercises the way your physiotherapist showed you? | 1 (0 to 1) |
| How confident are you that you understood how tiring the muscle strengthening exercises should feel? | 1 (0 to 1) |
| How likely are you to continue your exercises now your physiotherapy is finished? | 1 (0 to 1) |
Percentage (0-100%) of scheduled physiotherapy sessions attended
| Scheduled physiotherapy sessions | Individualized Exercise |
|---|---|
| Adherence | 56 |
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)
| Participants | Participants Who Completed and Returned Follow-up Outcome Data |
|---|---|
| 'Always' | 4 |
| 'Often' | 5 |
| 'Sometimes' | 2 |
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
| percentage of questions | Individualized Exercise |
|---|---|
| Baseline Lysholm Knee Scoring Scale | 100 |
| Baseline Tegner Activity Scale | 100 |
| Baseline EQ-5D-5L | 100 |
| Follow-up Lysholm Knee Scoring Scale | 100 |
| Follow-up Tegner Activity Scale | 100 |
| Follow-up EQ-5D-5L | 100 |
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.
| Participants | Individualized Exercise |
|---|---|
| knee pain or swelling after completing prescribed exercises that lasted >1 week | 1 |
| Recurrent patella dislocation | 1 |
| No treatment related adverse event | 13 |
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
| percentage | Patients With a Diagnosed Lateral Patellar Dislocation |
|---|---|
| Medial patellofemoral ligament tenderness | 100 |
| convincing history of a lateral patellar dislocation | 93.3 |
| visible knee joint effusion or haemarthrosis | 66.7 |
| positive patella apprehension test, | 100 |
This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.
| units on a scale | Participants Who Completed and Returned Follow-up Outcome Data |
|---|---|
| Tegner Activity Scale Questionnaire | 6 (3 to 7) |
It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.
| units on a scale | Patients Who Returned Lysholm Knee Scoring Scale Outcome Data |
|---|---|
| Lyhsolm Knee Scoring Scale Questionnaire | 90 (76.5 to 95) |
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.
| units on a scale | Participants Who Completed and Returned Follow-up Outcome Data |
|---|---|
| Index score | 0.84 (0.8 to 1) |
| Health on a Visual Analogue Scale | 90 (85 to 95) |
Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention
| Days | Individualized Exercise |
|---|---|
| Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] | 21 (15 to 27) |
Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants
| physiotherapy sessions | Individualized Exercise |
|---|---|
| Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] | 3 (3 to 5) |
Treatment logs will be analysed to assess the duration (days) of the study intervention
| Days | Individualized Exercise |
|---|---|
| Assess Delivery of the Intervention [Duration of Intervention] | 50 (37 to 79) |
Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants
| participants | Individualized Exercise |
|---|---|
| Knee flexibility exercise | 13 |
| Trunk and leg control exercise | 14 |
| Leg resistance exercise | 15 |
| Running exercise | 5 |
| Bespoke exercise | 5 |
Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants
| Prescribed leg resistance exercise | Individualized Exercise |
|---|---|
| Prescribed sets between 1-3 | 90 |
| Prescribed repetitions between 8-12 | 89 |
| Prescribed frequency 3 or more per week | 91 |
Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team
| Participants | Individualized Exercise |
|---|---|
| Lateral butress splint | 12 |
| Cricket pad splint | 2 |
| Hinged knee brace | 1 |
| Full weight-bearing | 15 |
| Two elbow crutches | 7 |
| No walking aids | 8 |
| Knee range of movement exercises | 7 |
| Non-weight bearing knee strengthening exercise | 4 |
| Gait practice, balance exercises | 2 |
| Weight-bearing knee strengthening, strengthening of unijured joints | 1 |
Collected over through 3 months after the first physiotherapy session. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individualized Exercise | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | Individualized Exercise |
|---|---|
| Knee pain or swelling after completing prescribed exercise that last >1 weekMusculoskeletal and connective tissue disorders | 1/15 |
| Recurrent patellar dislocationMusculoskeletal and connective tissue disorders | 1/15 |
| Age, Continuous(years) | Individualized Exercise |
|---|---|
| Median | 22 (19 to 28) |
| Sex: Female, Male(Participants) | Individualized Exercise |
|---|---|
| Female | 7 |
| Male | 8 |
| Race/Ethnicity, Customized(Participants) | Individualized Exercise |
|---|---|
| Ethnicity — White British | 13 |
| Ethnicity — White Other | 1 |
| Ethnicity — Other | 1 |
| Region of Enrollment(participants) | Individualized Exercise |
|---|---|
| United Kingdom | 15 |
| Height(meters) | Individualized Exercise |
|---|---|
| Median | 1.75 (1.62 to 1.8) |
| Weight(Kilograms) | Individualized Exercise |
|---|---|
| Median | 69.9 (64 to 85) |
| Education(Participants) | Individualized Exercise |
|---|---|
| Secondary education | 9 |
| Higher professional or University education | 6 |
| Employment status(Participants) | Individualized Exercise |
|---|---|
| Employed | 12 |
| Student | 3 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Jan 2019 to primary completion in Oct 2019, 8 months.
Results were first posted in Feb 2021, 1 year 3 months after primary completion.
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City, University of London