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Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain
This study has been completed.
Sponsor:
Aalborg University
Information provided by (Responsible Party):
Michael Skovdal Rathleff, Aalborg University
ClinicalTrials.gov Identifier:
NCT02674841
First received: February 1, 2016
Last updated: November 16, 2016
Last verified: November 2016
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Purpose
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 | Intervention |
|---|---|
| Patellofemoral Pain Syndrome Musculoskeletal Disorders Joint Diseases | Other: Feedback on TUT Other: No feedback on TUT Other: Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Michael Skovdal Rathleff, Aalborg University:
Primary Outcome Measures:
- 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:
- The total number of repetitions performed [ Time Frame: From 0-6 weeks ]
- 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
- Isometric strength [ Time Frame: At baseline and at the 6 week follow up ]Presented as Nm/kg in x, y and z direction
- 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
- 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
- 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"
- Summary of resistance [ Time Frame: From 0-6 weeks ]Total pulling force exerted during the course of the intervention measured in kilos
| Enrollment: | 40 |
| Study Start Date: | February 2016 |
| Study Completion Date: | October 2016 |
| Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02674841
Please refer to this study by its ClinicalTrials.gov identifier: NCT02674841
Locations
| Denmark | |
| Aalborg Universitetshospital | |
| Aalborg, The North Denmark Region, Denmark, 9000 | |
Sponsors and Collaborators
Aalborg University
Investigators
| Principal Investigator: | Michael S Rathleff, Ph.d. | Aalborg University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Skovdal Rathleff, Post.doc., Aalborg University |
| ClinicalTrials.gov Identifier: | NCT02674841 History of Changes |
| Other Study ID Numbers: |
N-20150070 |
| Study First Received: | February 1, 2016 |
| Last Updated: | November 16, 2016 |
| Individual Participant Data | |
| 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:
|
Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 29, 2017