Patellofemoral Pain SyndromeNCT02674841
Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain
A study testing Feedback on TUT, No feedback on TUT and Exercise in people with Patellofemoral Pain Syndrome and Musculoskeletal Disorders, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Musculoskeletal Disorders, Joint Diseases
- What is being tested?
- Feedback on TUT, No feedback on TUT and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg Universitetshospital
Aalborg, The North Denmark Region, 9000
About this study
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
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.
- Being tested
- Feedback on TUT, No feedback on TUT, Exercise
- Keywords
- Adolescent, Physical therapy modalities, Exercise intervention, Auditive feedback, Visual feedback
- Medical subject headings
- Patellofemoral Pain Syndrome, Musculoskeletal Diseases, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback on TUTOther
Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.
No feedback on TUTOther
Access only to live visual feedback on pulling force from an application on an iPad.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Feedback group | Experimental | Receives live feedback on TUT and pulling force during exercises. Receives: Other: Feedback on TUT; Other: Exercise |
| Control group | Active comparator | Receives no feedback on TUT but on pulling force during exercises. Receives: Other: No feedback on TUT; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 0-6 weeks
Secondary outcomes (7)
The total number of repetitions performed
Measured: From 0-6 weeks
Pulling force exerted per repetition measured in kilos
This will be expressed as the maximum pulling force during each repetition
Measured: From 0-6 weeks
Isometric strength
Presented as Nm/kg in x, y and z direction
Measured: At baseline and at the 6 week follow up
Pain measured on a 100 mm VAS
Is entered into the app by the adolescent before and after each exercise
Measured: From 0-6 weeks
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
Measured: At baseline and at the 6 week follow up
Global rating of change
Self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse"
Measured: At the 6 week follow up
Summary of resistance
Total pulling force exerted during the course of the intervention measured in kilos
Measured: From 0-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Skovdal Rathleff, Aalborg University
- Investigators
- Michael S Rathleff, Ph.d., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674841
- Sponsor's protocol ID
- N-20150070
- Status last verified
- Nov 2016
- First submitted
- 1 Feb 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02674841
- Acronym / sponsor ID
- N-20150070
- Keywords
- Adolescent, Physical therapy modalities, Exercise intervention, Auditive feedback, Visual feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback group | Experimental | Other: Feedback on TUT, Other: ExerciseReceives live feedback on TUT and pulling force during exercises. |
| Control group | Active comparator | Other: No feedback on TUT, Other: ExerciseReceives no feedback on TUT but on pulling force during exercises. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback on TUTAccess to live visual and auditory feedback on TUT and pulling force from an application on an iPad. | Other | Feedback group |
| No feedback on TUTAccess only to live visual feedback on pulling force from an application on an iPad. | Other | Control group |
| Exercise3 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. | Other | Control group, Feedback group |
Primary outcome
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
7 secondary outcomes
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
Isometric strength
Time frame: At baseline and at the 6 week follow up
Pain measured on a 100 mm VAS
Time frame: From 0-6 weeks
Kujala Patellofemoral Scale-score
Time frame: At baseline and at the 6 week follow up
Global rating of change
Time frame: At the 6 week follow up
Summary of resistance
Time frame: From 0-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Derived from this study: PubMed 27250984Riel 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Rathleff, Ph.d. principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback on TUT, No feedback on TUT and Exercise in people with Patellofemoral Pain Syndrome and Musculoskeletal Disorders, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention (time frame: From 0-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.