Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain
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ClinicalTrials.gov Identifier: NCT02674841 |
Recruitment Status :
Completed
First Posted : February 5, 2016
Last Update Posted : November 17, 2016
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Feedback group
Receives live feedback on TUT and pulling force during exercises.
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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.
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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. |
- 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
- 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

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Ages Eligible for Study: | 15 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Denmark | |
Aalborg Universitetshospital | |
Aalborg, The North Denmark Region, Denmark, 9000 |
Principal Investigator: | Michael S Rathleff, Ph.d. | Aalborg University |
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. |
Adolescent Physical therapy modalities Exercise intervention Auditive feedback Visual feedback |
Joint Diseases Patellofemoral Pain Syndrome Musculoskeletal Diseases |