- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03213015
Correlation Between the Amplitude of Ankle Dorsiflexion and Occurrence of Patellofemoral Pain Syndrome
July 10, 2017 updated by: Filipe Abdalla dos Reis
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mato Grosso do Sul
-
Campo Grande, Mato Grosso do Sul, Brazil, 79117504
- Filipe Abdalla
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- acute knee lesion
- acute ankle lesion
- surgical procedures before six months ago
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Measurement of ankle dorsiflexion ROM (range of motion) with iHand app (smartphone)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2017
Primary Completion (Actual)
March 25, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
July 4, 2017
First Submitted That Met QC Criteria
July 6, 2017
First Posted (Actual)
July 11, 2017
Study Record Updates
Last Update Posted (Actual)
July 13, 2017
Last Update Submitted That Met QC Criteria
July 10, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.128.451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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