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| ID | Type | Description | Link |
|---|---|---|---|
| 251913 | Other Identifier | Health Research Authority - IRAS ID |
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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized exercise | Experimental | Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Number of Treatment Related Adverse Events Experienced by Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Haddad, PhD | City, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34749823 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individualized Exercise | Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individualized Exercise | Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Eligibility Rate | Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria | These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment | Posted | Count of Participants | Participants | 15 weeks |
|
|
through 3 months after the first physiotherapy session
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individualized Exercise | Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee pain or swelling after completing prescribed exercise that last >1 week | Musculoskeletal and connective tissue disorders | Systematic Assessment | one participant reported knee pain or swelling after completing prescribed exercise that lasted more than 3 week on three separate occasions |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Forde | Oxford University hospital foundation trust | +441865221540 | Colin.Forde@ouh.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2018 | Dec 19, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D031222 | Patellar Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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|
| 12 weeks |
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. |
| 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 | 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. | 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. | 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. | 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 | 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 | 12 weeks |
| Assess Delivery of the Intervention [Duration of Intervention] | Treatment logs will be analysed to assess the duration (days) of the study intervention | 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 | 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 | 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 | From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Inter-Quartile Range | meters |
|
| Weight | Median | Inter-Quartile Range | Kilograms |
|
| Education | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Duration from injury to eligibility assessment | Mean | Inter-Quartile Range | days |
|
| Previous ipsilateral patellar dislocation | Count of Participants | Participants |
|
| Number of previous ipsilateral patellar dislocations | Count of Participants | Participants |
|
| Previous contralateral patellar dislocation | Count of Participants | Participants |
|
| Number of previous contralateral patellar dislocations (number of participants) | Count of Participants | Participants |
|
| Family history of patellar dislocation | Count of Participants | Participants |
|
|
| Primary | Recruitment Rate | Percentage of eligible participants who consented to participate in the study | Posted | Count of Participants | Participants | 15 weeks |
|
|
|
| Primary | Attrition | Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks |
|
|
|
| Primary | Adherence | Percentage (0-100%) of scheduled physiotherapy sessions attended | Posted | Count of Units | Scheduled physiotherapy sessions | 12 weeks | Scheduled physiotherapy sessions | Scheduled physiotherapy sessions |
|
|
|
| Primary | 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) | 11/15 participants completed and returned data for this outcome | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | 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 | 15 participants completed baseline patient-reported outcome measures and 11 participants completed all patient-reported outcome measures at 3-month follow-up and returned by post. Analysed data refers only to these participants. Lysholm Knee Scoring Scale outcome data was obtained for 2 participants by phone at 3-month follow-up, so they are not included in analysed data | Posted | Number | percentage of questions | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Through 12 weeks after first physiotherapy session |
|
|
|
| Secondary | 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 | 15 participants were assessed for all the clinical findings below, except for the patella apprehension test which was only assessed in 13 participants. | Posted | Number | percentage | Baseline |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 Weeks |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | Days | From date of injury until date of the first physiotherapy session, assessed up to 6 weeks |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | physiotherapy sessions | 12 weeks |
|
|
|
| Secondary | Assess Delivery of the Intervention [Duration of Intervention] | Treatment logs will be analysed to assess the duration (days) of the study intervention | Posted | Median | Inter-Quartile Range | Days | 12 weeks |
|
|
|
| Secondary | 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 | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | 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 | Posted | Count of Units | Prescribed leg resistance exercise | 12 weeks | Prescribed leg resistance exercise | Prescribed leg resistance exercise |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 2 |
| 15 |
|
| Recurrent patellar dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One participant who was lost to follow-up was later found to have experienced a recurrent patellar dislocation after she finished the study intervention |
|
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| D007718 |
| Knee Injuries |
| D007869 | Leg Injuries |
|
| How satisfied were you with the written information you were given describing the study? |
|
| How satisfied were you with the written information you were given about your injury? |
|
| How satisfied are you overall with the physiotherapy care you received after your injury? |
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| How confident are you that you can return to all your normal activities? |
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| How did doing your exercises fit into your weekly routine? |
|
| How confident are you that you were doing your exercises the way your physiotherapist showed you? |
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| How confident are you that you understood how tiring the muscle strengthening exercises should feel? |
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| How likely are you to continue your exercises now your physiotherapy is finished? |
|
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| Baseline EQ-5D-5L |
|
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| Follow-up Lysholm Knee Scoring Scale |
|
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| Follow-up Tegner Activity Scale |
|
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| Follow-up EQ-5D-5L |
|
|
|
| visible knee joint effusion or haemarthrosis |
|
|
| positive patella apprehension test, |
|
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| Title | Measurements |
|---|---|
|
| Running exercise |
|
| Bespoke exercise |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Full weight-bearing |
|
| Two elbow crutches |
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| No walking aids |
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| Knee range of movement exercises |
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| Non-weight bearing knee strengthening exercise |
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| Gait practice, balance exercises |
|
| Weight-bearing knee strengthening, strengthening of unijured joints |
|