Clinical trial NCT02674841: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Musculoskeletal Disorders
Joint Diseases
Keywords: Adolescent
Physical therapy modalities
Exercise intervention
Auditive feedback
Visual feedback
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention
timeFrame: From 0-6 weeks
Secondary outcomes:
measure: The total number of repetitions performed
timeFrame: From 0-6 weeks
measure: Pulling force exerted per repetition measured in kilos
timeFrame: From 0-6 weeks
measure: Isometric strength
timeFrame: At baseline and at the 6 week follow up
measure: Pain measured on a 100 mm VAS
timeFrame: From 0-6 weeks
measure: Kujala Patellofemoral Scale-score
timeFrame: At baseline and at the 6 week follow up
measure: Global rating of change
timeFrame: At the 6 week follow up
measure: Summary of resistance
timeFrame: From 0-6 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
state: The North Denmark Region
Study officials:
affiliation: Aalborg University
name: Michael S Rathleff, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
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.