Patellofemoral Pain SyndromeNCT03213015
Correlation Between the Amplitude of Ankle Dorsiflexion and Occurrence of Patellofemoral Pain Syndrome
A study testing Ankle dorsiflexion measurement in people with Patellofemoral Pain Syndrome, run by Filipe Abdalla dos Reis at 1 site in Brazil.
Trial summary
The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Ankle dorsiflexion measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jan 2017to 30 Jun 2017
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteers with a history of patelofemoral pain
- presence of image (lesion) in cartilage tissue in Nuclear Magnetic Resonance
- knee dynamic valgus during the single leg squat test and step down test (clinical tests)
Who cannot join
- acute knee lesion
- acute ankle lesion
- surgical procedures before six months ago
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.
Read the detailed description
The change in lower extremity movement pattern has been previously associated with severe knee disorders, including anterior cruciate ligament rupture, patellar tendinopathy, iliotibial band syndrome, and patellofemoral pain (PFP). The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Ankle dorsiflexion measurement
- Keywords
- confiability, ankle, patellofemoral pain syndrome
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle dorsiflexion measurementDiagnostic test
It was used the test with WB, called Lunge Test, in which each evaluator marked a point 15 cm distal to the anterior tuberosity of the tibia (TAT) with a felt tip pen. After that the smartphone (app iHand) will be placed at this point. Between each measurement, the mark was removed with alcohol 70% The demarcated point served as a guide for positioning the smartphone. In order to standardize the smartphone positioning, BHome (home button on the iPhone), was aligned with the TAT pen mark. To ensure the same distance from the foot to the test, the distance of the hallux to the wall was measured (tape measure), recorded and reused for each test.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Measurement of ankle dorsiflexion ROM (range of motion) with iHand app (smartphone) Receives: Diagnostic Test: Ankle dorsiflexion measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Dorsiflexion Degrees
We will evaluate the ankle range of motion (dorsiflexion) with app (iHand) in smartphone. The measurement will be in degree.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start25 Jan 2017
- Primary completion25 Mar 2017
- Study completion30 Jun 2017
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
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Filipe Abdalla dos Reis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Filipe Abdalla dos Reis, Universidade Anhanguera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213015
- Sponsor's protocol ID
- 2.128.451
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dill KE, Begalle RL, Frank BS, Zinder SM, Padua DA. Altered knee and ankle kinematics during squatting in those with limited weight-bearing-lunge ankle-dorsiflexion range of motion. J Athl Train. 2014 Nov-Dec;49(6):723-32. doi: 10.4085/1062-6050-49.3.29.
PubMed 25144599
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Amplitude of Ankle Dorsiflexion and Occurrence of Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03213015
- Acronym / sponsor ID
- 2.128.451
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- confiability, ankle, patellofemoral pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Filipe Abdalla dos ReisUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 25 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.
Detailed description
The change in lower extremity movement pattern has been previously associated with severe knee disorders, including anterior cruciate ligament rupture, patellar tendinopathy, iliotibial band syndrome, and patellofemoral pain (PFP). The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Ankle dorsiflexion measurementMeasurement of ankle dorsiflexion ROM (range of motion) with iHand app (smartphone) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- volunteers with a history of patelofemoral pain
- presence of image (lesion) in cartilage tissue in Nuclear Magnetic Resonance
- knee dynamic valgus during the single leg squat test and step down test (clinical tests)
Key exclusion criteria (3 listed)
- acute knee lesion
- acute ankle lesion
- surgical procedures before six months ago
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 |
|---|---|---|
| Ankle dorsiflexion measurementIt was used the test with WB, called Lunge Test, in which each evaluator marked a point 15 cm distal to the anterior tuberosity of the tibia (TAT) with a felt tip pen. After that the smartphone (app iHand) will be placed at this point. Between each measurement, the mark was removed with alcohol 70% The demarcated point served as a guide for positioning the smartphone. In order to standardize the smartphone positioning, BHome (home button on the iPhone), was aligned with the TAT pen mark. To ensure the same distance from the foot to the test, the distance of the hallux to the wall was measured (tape measure), recorded and reused for each test. | Diagnostic test | Experimental |
Primary outcome
Ankle Dorsiflexion Degrees
Time frame: 1 day
We will evaluate the ankle range of motion (dorsiflexion) with app (iHand) in smartphone. The measurement will be in degree.
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 13 Jul 2017.
- Results publication: PubMed 25144599Dill KE, Begalle RL, Frank BS, Zinder SM, Padua DA. Altered knee and ankle kinematics during squatting in those with limited weight-bearing-lunge ankle-dorsiflexion range of motion. J Athl Train. 2014 Nov-Dec;49(6):723-32. doi: 10.4085/1062-6050-49.3.29.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle dorsiflexion measurement in people with Patellofemoral Pain Syndrome, run by Filipe Abdalla dos Reis at 1 site in Brazil.
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 3 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 13 Jul 2017. 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 Brazil. 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?
Ankle Dorsiflexion Degrees (time frame: 1 day). 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 NCT03213015, 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 13 Jul 2017.