Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Joint Diseases; Patellofemoral Pain Syndrome; Musculoskeletal Disorders
• Intervention / Treatment: Other: Feedback on TUT; Other: Exercise; Other: No feedback on TUT

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • The North Denmark Region
    • Aalborg, The North Denmark Region, Denmark, 9000
      • Aalborg Universitetshospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feedback group; Receives live feedback on TUT and pulling force during exercises.	Other: Feedback on TUT; Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.; Other: 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.
Active Comparator: Control group; Receives no feedback on TUT but on pulling force during exercises.	Other: 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.; Other: No feedback on TUT; Access only to live visual feedback on pulling force from an application on an iPad.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aalborg University
• Investigators: Principal Investigator: Michael S Rathleff, Ph.d., Aalborg University

Publications and helpful links

General Publications

• Riel H, Matthews M, Vicenzino B, Bandholm T, Thorborg K, Rathleff MS. Efficacy of live feedback to improve objectively monitored compliance to prescribed, home-based, exercise therapy-dosage in 15 to 19 year old adolescents with patellofemoral pain- a study protocol of a randomized controlled superiority trial (The XRCISE-AS-INSTRUcted-1 trial). BMC Musculoskelet Disord. 2016 Jun 2;17:242. doi: 10.1186/s12891-016-1103-y.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Adolescent; Physical therapy modalities; Exercise intervention; Visual feedback; Auditive feedback
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: N-20150070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: No later than 1 year after the final follow-up, a completely anonymised data set to an appropriate data archive for sharing purposes will be delivered.