Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05882981 |
| Other study ID # |
DT-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 20, 2023 |
| Est. completion date |
January 14, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Bezmialem Vakif University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
It is important to determine how high femoral anteversion, which is one of the lower
extremity malalignments, affects physical performance and to what extent it affects the daily
life of the individual. As far as we know, there is no study on this subject except for a
study conducted by Staheli et al. in 1977. Therefore, the investigators planned to determine
whether and to what extent high femoral anteversion has an effect on physical performance in
healthy young adults.
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".
