Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674841
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Skovdal Rathleff, Aalborg University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Musculoskeletal Disorders Joint Diseases Other: Feedback on TUT Other: No feedback on TUT Other: Exercise Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: No feedback on TUT
Access only to live visual feedback on 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674841


Locations
Layout table for location information
Denmark
Aalborg Universitetshospital
Aalborg, The North Denmark Region, Denmark, 9000
Sponsors and Collaborators
Aalborg University
Investigators
Layout table for investigator information
Principal Investigator: Michael S Rathleff, Ph.d. Aalborg University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Michael Skovdal Rathleff, Post.doc., Aalborg University
ClinicalTrials.gov Identifier: NCT02674841    
Other Study ID Numbers: N-20150070
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Michael Skovdal Rathleff, Aalborg University:
Adolescent
Physical therapy modalities
Exercise intervention
Auditive feedback
Visual feedback
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Patellofemoral Pain Syndrome
Musculoskeletal Diseases