Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

NCT ID: NCT02674841

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patellofemoral Pain Syndrome Musculoskeletal Disorders Joint Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Adolescent Physical therapy modalities Exercise intervention Auditive feedback Visual feedback

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Feedback group

Receives live feedback on TUT and pulling force during exercises.

Group Type EXPERIMENTAL

Feedback on TUT

Intervention Type OTHER

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

Exercise

Intervention Type OTHER

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.

Control group

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

Group Type ACTIVE_COMPARATOR

No feedback on TUT

Intervention Type OTHER

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

Exercise

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Feedback on TUT

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

Intervention Type OTHER

No feedback on TUT

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Skovdal Rathleff

Post.doc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael S Rathleff, Ph.d.

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aalborg Universitetshospital

Aalborg, The North Denmark Region, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27250984 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-20150070

Identifier Type: -

Identifier Source: org_study_id