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Completed

NCT Number: NCT02674841

Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

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.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases Musculoskeletal Disorders

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Universitetshospital

Aalborg, The North Denmark Region, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feedback on TUT

Other

Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.

No feedback on TUT

Other

Access only to live visual feedback on pulling force from an application on an iPad.

Exercise

Other

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.

Primary outcomes

  1. Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention

    Time frame: From 0-6 weeks

    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

Secondary outcomes

  1. The total number of repetitions performed

    Time frame: From 0-6 weeks

  2. Pulling force exerted per repetition measured in kilos

    Time frame: From 0-6 weeks

    This will be expressed as the maximum pulling force during each repetition

  3. Isometric strength

    Time frame: At baseline and at the 6 week follow up

    Presented as Nm/kg in x, y and z direction

  4. Pain measured on a 100 mm VAS

    Time frame: From 0-6 weeks

    Is entered into the app by the adolescent before and after each exercise

  5. Kujala Patellofemoral Scale-score

    Time frame: At baseline and at the 6 week follow up

    Gives a score on patellofemoral pain ranging from 0 to 100 with 0 as complete disability and 100 as fully functional

  6. Global rating of change

    Time frame: At the 6 week follow up

    Self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse"

  7. Summary of resistance

    Time frame: From 0-6 weeks

    Total pulling force exerted during the course of the intervention measured in kilos

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2016
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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