Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

Study Overview
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Brief Summary
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This study investigates if live feedback during home-based exercises will improve the ability to perform the exercises with the prescribed time under tension (TUT) per repetition compared with no feedback among adolescents with patellofemoral pain. The hypothesis is that adolescents who receive live feedback from BandCizer™ will have a mean TUT that is significantly closer to the prescribed TUT compared to the group not receiving feedback during the course of the intervention.

Official Title
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Efficacy of Live Feedback to Increase Objectively Monitored Adherence to Prescribed, Home-based, Exercise Therapy-dosage in 15 to 19 Year Old Adolescents With Patellofemoral Pain. A Randomized Controlled Superiority Trial

Conditions
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Patellofemoral Pain Syndrome, Musculoskeletal Disorders, Joint Diseases

Intervention / Treatment
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* Other: Feedback on TUT
* Other: No feedback on TUT
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15 to 19 years of age Anterior knee pain of non-traumatic origin which is provoked by at least two of the following activities: prolonged sitting with bended knees or kneeling, squatting, running, jumping or ascending or descending stairs Tenderness on palpation of the peripatellar borders Pain of more than 6 weeks duration Worst pain during the previous week ≥ 30 mm on a 100 mm VAS Exclusion Criteria: Concomitant pain from other structures in the knee (e.g. ligament, tendon or cartilage), the hip or the lumbar spine Previous knee surgery Patellofemoral instability

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback group<br>Receives live feedback on TUT and pulling force during exercises. | Other: Feedback on TUT<br>* Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.<br>Other: Exercise<br>* 3 exercises (knee extension, hip abduction and hip extension) using an elastic band with 3 sets of 10 repetitions at 10-12 RM 3 times a week for 6 weeks.<br>|
| Active Comparator: Control group<br>Receives no feedback on TUT but on pulling force during exercises. | Other: No feedback on TUT<br>* Access only to live visual feedback on pulling force from an application on an iPad.<br>Other: Exercise<br>* 3 exercises (knee extension, hip abduction and hip extension) using an elastic band with 3 sets of 10 repetitions at 10-12 RM 3 times a week for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention | The mean deviation is calculated as the difference between actual TUT and prescribed TUT (8 seconds). E.g. if the actual TUT is 6.5 seconds, the deviation is 1.5 seconds | From 0-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of repetitions performed |  | From 0-6 weeks | 
| Pulling force exerted per repetition measured in kilos | This will be expressed as the maximum pulling force during each repetition | From 0-6 weeks | 
| Isometric strength | Presented as Nm/kg in x, y and z direction | At baseline and at the 6 week follow up | 
| Pain measured on a 100 mm VAS | Is entered into the app by the adolescent before and after each exercise | From 0-6 weeks | 
| Kujala Patellofemoral Scale-score | Gives a score on patellofemoral pain ranging from 0 to 100 with 0 as complete disability and 100 as fully functional | At baseline and at the 6 week follow up | 
| Global rating of change | Self-reported recovery on a 7-point Likert scale ranging from much improved to much worse | At the 6 week follow up | 
| Summary of resistance | Total pulling force exerted during the course of the intervention measured in kilos | From 0-6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auditive feedback, Adolescent, Physical therapy modalities, Exercise intervention, Visual feedback