Back to resultsLive Feedback to Increase Adherence in Adolescents With Patellofemoral Pain
Primary Purpose
Patellofemoral Pain Syndrome, Musculoskeletal Disorders, Joint Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Feedback on TUT
No feedback on TUT
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Adolescent, Physical therapy modalities, Exercise intervention, Auditive feedback, Visual feedback
Eligibility 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
Sites / Locations
- Aalborg Universitetshospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Feedback group
Control group
Arm Description
Receives live feedback on TUT and pulling force during exercises.
Receives no feedback on TUT but on pulling force during exercises.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The total number of repetitions performed
Pulling force exerted per repetition measured in kilos
This will be expressed as the maximum pulling force during each repetition
Isometric strength
Presented as Nm/kg in x, y and z direction
Pain measured on a 100 mm VAS
Is entered into the app by the adolescent before and after each exercise
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
Global rating of change
Self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse"
Summary of resistance
Total pulling force exerted during the course of the intervention measured in kilos
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02674841
Brief Title
Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Musculoskeletal Disorders, Joint Diseases
Keywords
Adolescent, Physical therapy modalities, Exercise intervention, Auditive feedback, Visual feedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feedback group
Arm Type
Experimental
Arm Description
Receives live feedback on TUT and pulling force during exercises.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Receives no feedback on TUT but on pulling force during exercises.
Intervention Type
Other
Intervention Name(s)
Feedback on TUT
Intervention Description
Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.
Intervention Type
Other
Intervention Name(s)
No feedback on TUT
Intervention Description
Access only to live visual feedback on pulling force from an application on an iPad.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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 Outcome Measure Information:
Title
Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention
Description
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
Time Frame
From 0-6 weeks
Secondary Outcome Measure Information:
Title
The total number of repetitions performed
Time Frame
From 0-6 weeks
Title
Pulling force exerted per repetition measured in kilos
Description
This will be expressed as the maximum pulling force during each repetition
Time Frame
From 0-6 weeks
Title
Isometric strength
Description
Presented as Nm/kg in x, y and z direction
Time Frame
At baseline and at the 6 week follow up
Title
Pain measured on a 100 mm VAS
Description
Is entered into the app by the adolescent before and after each exercise
Time Frame
From 0-6 weeks
Title
Kujala Patellofemoral Scale-score
Description
Gives a score on patellofemoral pain ranging from 0 to 100 with 0 as complete disability and 100 as fully functional
Time Frame
At baseline and at the 6 week follow up
Title
Global rating of change
Description
Self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse"
Time Frame
At the 6 week follow up
Title
Summary of resistance
Description
Total pulling force exerted during the course of the intervention measured in kilos
Time Frame
From 0-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Rathleff, Ph.d.
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Universitetshospital
City
Aalborg
State/Province
The North Denmark Region
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
27250984
Citation
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.
Results Reference
derived
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Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain
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