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NCT03798483: INDEX-KD

INDividualised EXercise for Kneecap Dislocations

Completed NA Results posted Last updated 1 February 2021
What this trial tests

NA trial testing Individualised exercise in Patella Dislocation in 15 participants. Completed in 15 October 2019.

Timeline
24 January 2019
Primary endpoint
8 October 2019
15 October 2019

Quick facts

Lead sponsorCity, University of London
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date24 January 2019
Primary completion8 October 2019
Estimated completion15 October 2019
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

City, University of London

Who can join

16 and older, any sex, with Patella Dislocation or Patella Dislocation Recurrent. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Eligibility Rate Primary · 15 weeks

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

GroupValue95% CI
Patients With a Diagnosed Lateral Patellar Dislocation15
Recruitment Rate Primary · 15 weeks

Percentage of eligible participants who consented to participate in the study

GroupValue95% CI
Individualized Exercise15
Attrition Primary · 12 weeks

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

GroupValue95% CI
Individualized Exercise2
Acceptability [Participant Satisfaction]: Questionnaire Primary · 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.

How satisfied are you with the effect of your physiotherapy treatment?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data00 – 0
How satisfied are you with your involvement in decision making about your physiotherapy treatment?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data00 – 0
How satisfied were you with up to six physiotherapy sessions over three months after your injury?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data00 – 0
How satisfied were you with the written information you were given describing the study?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data00 – 0
How satisfied were you with the written information you were given about your injury?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data00 – 1
How satisfied are you overall with the physiotherapy care you received after your injury?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data00 – 0
How confident are you that you can return to all your normal activities?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data00 – 1
How did doing your exercises fit into your weekly routine?
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data10 – 2
Adherence Primary · 12 weeks

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

GroupValue95% CI
Individualized Exercise56
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] Primary · 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)

GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data4
Participants Who Completed and Returned Follow-up Outcome Data5
Participants Who Completed and Returned Follow-up Outcome Data2
Acceptability of Outcome Data Collection Secondary · 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

Baseline Lysholm Knee Scoring Scale
GroupValue95% CI
Individualized Exercise100
Baseline Tegner Activity Scale
GroupValue95% CI
Individualized Exercise100
Baseline EQ-5D-5L
GroupValue95% CI
Individualized Exercise100
Follow-up Lysholm Knee Scoring Scale
GroupValue95% CI
Individualized Exercise100
Follow-up Tegner Activity Scale
GroupValue95% CI
Individualized Exercise100
Follow-up EQ-5D-5L
GroupValue95% CI
Individualized Exercise100
Number of Treatment Related Adverse Events Experienced by Participants Secondary · 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.

GroupValue95% CI
Individualized Exercise1
Individualized Exercise1
Individualized Exercise13
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Secondary · 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 r

Medial patellofemoral ligament tenderness
GroupValue95% CI
Patients With a Diagnosed Lateral Patellar Dislocation100
convincing history of a lateral patellar dislocation
GroupValue95% CI
Patients With a Diagnosed Lateral Patellar Dislocation93.3
visible knee joint effusion or haemarthrosis
GroupValue95% CI
Patients With a Diagnosed Lateral Patellar Dislocation66.7
positive patella apprehension test,
GroupValue95% CI
Patients With a Diagnosed Lateral Patellar Dislocation100
Tegner Activity Scale Questionnaire Secondary · 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.

GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data63 – 7
Lyhsolm Knee Scoring Scale Questionnaire Secondary · 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.

GroupValue95% CI
Patients Who Returned Lysholm Knee Scoring Scale Outcome Data9076.5 – 95
Quality of Life Using the EQ-5D-5L Questionnaire Secondary · 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.

Index score
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data0.840.8 – 1
Health on a Visual Analogue Scale
GroupValue95% CI
Participants Who Completed and Returned Follow-up Outcome Data9085 – 95

Adverse events — posted to ClinicalTrials.gov

Time frame: through 3 months after the first physiotherapy session. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Individualized Exercise
Serious: 0/15 (0%)
Deaths: 0/15
Other adverse events (2 terms — click to expand)

ReactionSystemIndividualized Exercise
Knee pain or swelling after completing prescribed exercise that last >1 weekMusculoskeletal and connective tissue disorders
Recurrent patellar dislocationMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT03798483 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study.
    Forde C, Haddad M, Hirani SP, Keene DJ. · · 2021 · cited 4× · PMID 34749823 · DOI 10.1186/s40814-021-00932-x
  2. Is an Individually Tailored Programme of Intense Leg Resistance and Dynamic Exercise Acceptable to Adults with an Acute Lateral Patellar Dislocation? A Feasibility Study
    Forde C, Haddad M, Hirani SP, Keene DJ. · · 2020 · DOI 10.21203/rs.3.rs-84996/v1

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