Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674841
• Other study ID #: N-20150070
• Status: Completed
• Phase: N/A
• First received: February 1, 2016
• Last updated: November 16, 2016
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Musculoskeletal Diseases
• Musculoskeletal Disorders
• Patellofemoral Pain Syndrome

Intervention

Other:
• Feedback on TUT
Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.
• No feedback on TUT
Access only to live visual feedback on pulling force from an application on an iPad.
• Exercise
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.

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg	The North Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The total number of repetitions performed		From 0-6 weeks	No
Secondary	Pulling force exerted per repetition measured in kilos	This will be expressed as the maximum pulling force during each repetition	From 0-6 weeks	No
Secondary	Isometric strength	Presented as Nm/kg in x, y and z direction	At baseline and at the 6 week follow up	No
Secondary	Pain measured on a 100 mm VAS	Is entered into the app by the adolescent before and after each exercise	From 0-6 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Summary of resistance	Total pulling force exerted during the course of the intervention measured in kilos	From 0-6 weeks	No