- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05882981
Increased Femoral Anteversion and Physical Performance
Evaluation of Physical Performance of Young Adults With Increased Femoral Anteversion
Study Overview
Status
Conditions
Detailed Description
One of the factors associated with problems in the lower extremity is changes in the angle of femoral anteversion. High femoral anteversion causes pathological changes in the sagittal and coronal planes, especially in the transverse plane, and changes the gait biomechanics. Femoral anteversion angle; It is the angle formed by the plane of the femoral condyle and the plane passing through the femoral neck and the femoral head. The femoral anteversion angle, which is 55°-60° in the intrauterine period, is approximately 30° at birth. In the postnatal period, with normal growth, it decreases by 1.5° per year until the age of 15, decreasing to 26° at the age of 5, 21° at the age of 9 and 15° at the age of 16.
Toe-in gait pattern may be due to foot deformity (metatarsus adductus) and/or transverse alignment disorder of the long bones (tibial torsion and/or femoral anteversion height). When the angle of anterversion is high, walking with the feet turned in is 30.9% at the age of 4, 15% at the age of 4, and around 4% in adults. High femoral anteversion, which is the most common cause of inward walking in early childhood, is mostly seen symmetrically, with a higher incidence in girls and hypermobile children. Most cases are idiopathic and some patients have a familial predisposition.
Alignment disorders in the lower extremities can cause problems affecting other segments of the body, postural disorders and problems in the musculoskeletal system, as well as affect physical performance. The study, which will examine the physical performance status of young adults with high femoral anteversion, will be carried out as a cross-sectional study. The universe of the study will consist of students aged 17-26 who continue their education at the Faculty of Health Sciences of Bezmialem Vakıf University in the 2022-2023 academic year. Within the scope of our cross-sectional study, an application will be made for the approval of the Ethics Committee before the data are collected. The study, which will start after the permission is obtained, will be carried out in accordance with the Declaration of Helsinki. Evaluation and testing of all cases will be done at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. 22 subjects with high femoral anteversion angle and 22 subjects with normal femoral anteversion angle will be included in the study. Within the scope of the study, demographic information of all participants will be obtained with the evaluation form and clinical evaluations will be made. Flexibility with sit-reach test, hand grip strength with hydraulic hand dynamometer, general muscle strength with analog back-leg-chest dynamometer, functional performance with single-leg and double-leg horizontal jump tests, and functional capacities with 6-minute walking test will be evaluated. "Statistical Package for the Social Sciences (SPSS) 20.0 for Windows" package program will be used in the statistical analysis of the data obtained from the study which the investigators planned to evaluate physical performance in young adults with high femoral anteversion. All data will be analyzed with the Kolmogorov-Smirnov test to determine the distribution characteristics. In the study, descriptive statistics (mean±standard deviation, minimum-maximum, number and percentile) will be given for discrete and continuous variables. When the differences between two independent groups are evaluated, "t-Test in Independent Groups" in case the parametric test prerequisites are met; If not, the "Mann Whitney -U Test" will be used. "Chi-Square Test" will be used to determine the relationships between two discrete variables. When the variables meet the parametric test prerequisites, the correlation coefficients and statistical significance will be calculated with the "Pearson Test", when they do not, the correlation coefficients and statistical significance for the relations between the variables will be calculated with the "Spearman Test".
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Bezmialem Vakif University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Bilateral increased femoral anteversion
- Hip internal rotation >60 degrees, external rotation <45
- According to the Craig test, the anteversion angle is between 20-40 degrees
- Absence of a history of neurological or psychiatric disease
- Absence of intellectual disability to prevent participation in assessment and treatment
- Not participating in any exercise/physiotherapy program in the last six months
- Body mass index within normal limits (18.5-24.9 kg/m2)
Exclusion Criteria:
- Having a history of BoNT-A or surgery in the last 6 months
- Leg length inequality
- Beighton score of 4 and above
- Presence of 3rd degree pes planus
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group
22 young adults aged 17-26 years with high femoral anteversion.
|
It will be used to measure the flexibility of the participants.
Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.
An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.
Single-leg and double-leg horizontal jump test will be used to evaluate lower extremity functional performance.
The tests will be carried out according to the Eurofit test battery (Council of Europe, 1988).
Functional capacity will be evaluated with six minute walk test according to the ATS criteria.
|
Control group
22 young adults aged 17-26 years with normal femoral anteversion
|
It will be used to measure the flexibility of the participants.
Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.
An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.
Single-leg and double-leg horizontal jump test will be used to evaluate lower extremity functional performance.
The tests will be carried out according to the Eurofit test battery (Council of Europe, 1988).
Functional capacity will be evaluated with six minute walk test according to the ATS criteria.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional performance tests
Time Frame: One day
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Single-leg and double-leg horizontal jump test will be used to evaluate lower extremity functional performance.
The tests will be carried out according to the Eurofit test battery (Council of Europe, 1988).
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One day
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Functional capacity measurement
Time Frame: One day
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Functional capacity will be evaluated with six minute walk test according to the ATS criteria.
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One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sit and reach test
Time Frame: One day
|
It will be used to measure the flexibility of the participants.
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One day
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Back-leg-chest muscle strength measurement
Time Frame: One day
|
An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.
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One day
|
Hand grip strength measurement
Time Frame: One day
|
Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.
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One day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DT-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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