INDEX-KD: INDividualised EXercise for Kneecap Dislocations

• Sponsor: City, University of London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03798483
• Collaborator: Oxford University Hospitals NHS Trust (Other)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.7
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patella Dislocation; Patella Dislocation Recurrent	Other: Individualised exercise	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Jan 24, 2019
• Actual Primary Completion Date: Oct 8, 2019
• Actual Study Completion Date: Oct 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Eligibility Rate [15 weeks]

   Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria

2. Recruitment Rate [15 weeks]

   Percentage of eligible participants who consented to participate in the study

3. Attrition [12 weeks]

   Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data

4. Acceptability [Participant Satisfaction]: Questionnaire [12 weeks]

   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.

5. Adherence [12 weeks]

   Percentage (0-100%) of scheduled physiotherapy sessions attended

6. Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] [12 weeks]

   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

1. Acceptability of Outcome Data Collection [12 weeks]

   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

2. Number of Treatment Related Adverse Events Experienced by Participants [Through 12 weeks after first physiotherapy session]

   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.

3. Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria [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 [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 [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 [12 weeks]

   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.

7. Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] [From date of injury until date of the first physiotherapy session, assessed up to 6 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] [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] [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] [12 weeks]

    Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants

11. Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] [12 weeks]

    Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants

12. Assess Delivery of the Intervention [Initial Injury Management] [From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks]

    Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Radcliffe Hospital	Oxford		United Kingdom	OX3 9DU

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)

• Study Protocol and Statistical Analysis Plan - Dec 17, 2018

More Information

Publications

None provided.

• Responsible Party: City, University of London
• ClinicalTrials.gov Identifier: NCT03798483
• Other Study ID Numbers: MRes/18-19/04/2; 251913
• First Posted: Jan 10, 2019
• Last Update Posted: Feb 1, 2021
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• 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

Study Results

Participant Flow

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Period Title: Overall Study
STARTED	15
Returned All Follow-up Outcome Data	11
COMPLETED	13
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Overall Participants	15
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	22
Sex: Female, Male (Count of Participants)
Female	7 46.7%
Male	8 53.3%
Race/Ethnicity, Customized (Count of Participants)
White British	13 86.7%
White Other	1 6.7%
Other	1 6.7%
Region of Enrollment (participants) [Number]
United Kingdom	15 100%
Height (meters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [meters]	1.75
Weight (Kilograms) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Kilograms]	69.9
Education (Count of Participants)
Secondary education	9 60%
Higher professional or University education	6 40%
Employment status (Count of Participants)
Employed	12 80%
Student	3 20%
Duration from injury to eligibility assessment (days) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [days]	2
Previous ipsilateral patellar dislocation (Count of Participants)
Count of Participants [Participants]	5 33.3%
Number of previous ipsilateral patellar dislocations (Count of Participants)
0	10 66.7%
1	1 6.7%
2	1 6.7%
3	1 6.7%
4	1 6.7%
5-6	1 6.7%
Previous contralateral patellar dislocation (Count of Participants)
Count of Participants [Participants]	3 20%
Number of previous contralateral patellar dislocations (number of participants) (Count of Participants)
0	12 80%
1	1 6.7%
2	1 6.7%
>10	1 6.7%
Family history of patellar dislocation (Count of Participants)
Count of Participants [Participants]	1 6.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment

Arm/Group Title	Patients With a Diagnosed Lateral Patellar Dislocation
Arm/Group Description	Patients with a clinically diagnosed lateral patellar dislocation
Measure Participants	22
Count of Participants [Participants]	15 100%

2. Primary Outcome

Title	Recruitment Rate
Description	Percentage of eligible participants who consented to participate in the study
Time Frame	15 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Count of Participants [Participants]	15 100%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Count of Participants [Participants]	2 13.3%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Who Completed and Returned Follow-up Outcome Data
Arm/Group Description	11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants
Measure Participants	11
How satisfied are you with the effect of your physiotherapy treatment?	0
How satisfied are you with your involvement in decision making about your physiotherapy treatment?	0
How satisfied were you with up to six physiotherapy sessions over three months after your injury?	0
How satisfied were you with the written information you were given describing the study?	0
How satisfied were you with the written information you were given about your injury?	0
How satisfied are you overall with the physiotherapy care you received after your injury?	0
How confident are you that you can return to all your normal activities?	0
How did doing your exercises fit into your weekly routine?	1
How confident are you that you were doing your exercises the way your physiotherapist showed you?	1
How confident are you that you understood how tiring the muscle strengthening exercises should feel?	1
How likely are you to continue your exercises now your physiotherapy is finished?	1

5. Primary Outcome

Title	Adherence
Description	Percentage (0-100%) of scheduled physiotherapy sessions attended
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Measure Scheduled physiotherapy sessions	66
Count of Units [Scheduled physiotherapy sessions]	56

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

11/15 participants completed and returned data for this outcome

Arm/Group Title	Participants Who Completed and Returned Follow-up Outcome Data
Arm/Group Description	11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants
Measure Participants	11
'Always'	4 26.7%
'Often'	5 33.3%
'Sometimes'	2 13.3%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
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

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist 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.
Measure Participants	15
knee pain or swelling after completing prescribed exercises that lasted >1 week	1 6.7%
Recurrent patella dislocation	1 6.7%
No treatment related adverse event	13 86.7%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

15 participants were assessed for all the clinical findings below, except for the patella apprehension test which was only assessed in 13 participants.

Arm/Group Title	Patients With a Diagnosed Lateral Patellar Dislocation
Arm/Group Description	Patients with a clinically diagnosed lateral patellar dislocation
Measure Participants	15
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

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Who Completed and Returned Follow-up Outcome Data
Arm/Group Description	11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants
Measure Participants	11
Median (Inter-Quartile Range) [units on a scale]	6

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Who Returned Lysholm Knee Scoring Scale Outcome Data
Arm/Group Description	13 participants returned Lysholm Knee Scoring Scale data, for 2 of these participants outcome data was obtained by phone
Measure Participants	13
Median (Inter-Quartile Range) [units on a scale]	90

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Who Completed and Returned Follow-up Outcome Data
Arm/Group Description	11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants
Measure Participants	11
Index score	0.84
Health on a Visual Analogue Scale	90

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Median (Inter-Quartile Range) [Days]	21

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Median (Inter-Quartile Range) [physiotherapy sessions]	3

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Median (Inter-Quartile Range) [Days]	50

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Knee flexibility exercise	13 86.7%
Trunk and leg control exercise	14 93.3%
Leg resistance exercise	15 100%
Running exercise	5 33.3%
Bespoke exercise	5 33.3%

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Measure Prescribed leg resistance exercise	93
Prescribed sets between 1-3	90
Prescribed repetitions between 8-12	89
Prescribed frequency 3 or more per week	91

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
Measure Participants	15
Lateral butress splint	12 80%
Cricket pad splint	2 13.3%
Hinged knee brace	1 6.7%
Full weight-bearing	15 100%
Two elbow crutches	7 46.7%
No walking aids	8 53.3%
Knee range of movement exercises	7 46.7%
Non-weight bearing knee strengthening exercise	4 26.7%
Gait practice, balance exercises	2 13.3%
Weight-bearing knee strengthening, strengthening of unijured joints	1 6.7%

Adverse Events

Time Frame	through 3 months after the first physiotherapy session
Arm/Group Title	Individualized Exercise
Arm/Group Description	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.
All Cause Mortality
	Individualized Exercise
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Individualized Exercise
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Individualized Exercise
	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)
Musculoskeletal and connective tissue disorders
Knee pain or swelling after completing prescribed exercise that last >1 week	1/15 (6.7%)	3
Recurrent patellar dislocation	1/15 (6.7%)	1

Limitations/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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.