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CompletedNCT02674841Updated Nov 17, 2016

Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

An interventional study of Feedback on TUT and No feedback on TUT in Patellofemoral Pain Syndrome, Musculoskeletal Disorders and Joint Diseases, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 15 Years to 19 Years. Per ClinicalTrials.gov, last updated 2016-11-17.

Sponsored by Aalborg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
15 Years to 19 Years
Sex
All
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Study 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.

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Conditions studied

  • Patellofemoral Pain Syndrome
  • Musculoskeletal Disorders
  • Joint Diseases

Keywords

  • Adolescent
  • Physical therapy modalities
  • Exercise intervention
  • Auditive feedback
  • Visual feedback
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In context

Patellofemoral Pain Syndrome

295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 242 interventional studies indexed under Patellofemoral Pain Syndrome.

Browse Patellofemoral Pain Syndrome studies →

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Feedback group

    Receives live feedback on TUT and pulling force during exercises.

    Other: Feedback on TUT · Other: Exercise

  • Active comparator
    Control group

    Receives no feedback on TUT but on pulling force during exercises.

    Other: No feedback on TUT · Other: Exercise

Interventions

  • OtherFeedback on TUT

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

  • OtherNo feedback on TUT

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

  • OtherExercise

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: From 0-6 weeks

Secondary outcomes

  1. The total number of repetitions performed

    Time frame: From 0-6 weeks

  2. Pulling force exerted per repetition measured in kilos

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

    Time frame: From 0-6 weeks

  3. Isometric strength

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

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

  4. Pain measured on a 100 mm VAS

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

    Time frame: From 0-6 weeks

  5. 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

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

  6. Global rating of change

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

    Time frame: At the 6 week follow up

  7. Summary of resistance

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

    Time frame: From 0-6 weeks

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Study locations

1 site
  • Aalborg Universitetshospital
    Aalborg, The North Denmark Region 9000, Denmark
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References and documents

Publications

  • 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. PubMed 27250984 ↗

Individual participant data

Plan to share: Yes — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02674841
Lead sponsor
Aalborg University
Responsible party
Michael Skovdal Rathleff (Post.doc., Aalborg University) — Principal investigator
First posted
Feb 5, 2016
Start date
Feb 2016
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Nov 17, 2016

Study contacts

Michael S Rathleff, Ph.d.
principal investigator · Aalborg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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