AzTrials
AzTrials

High Femoral AnteversionNCT05882981

Increased Femoral Anteversion and Physical Performance

An observational study of High Femoral Anteversion and Muscle Strength, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 17 to 26 yearsHealthy volunteers can take part
What is being tested?
Sit and reach test, Hand grip strength measurement and Back-leg-chest muscle strength measurement
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Oct 2023to 14 Jan 2024
Phase
Observational
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 17 to 26 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: 22 young adults aged 17-26 years with high femoral anteversion.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bezmialem Vakif University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Physical Performance of Young Adults With Increased Femoral Anteversion

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.

Read the 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".

Being tested
Sit and reach test, Hand grip strength measurement, Back-leg-chest muscle strength measurement, Functional performance, Functional capacity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sit and reach testOther

    It will be used to measure the flexibility of the participants.

  • Hand grip strength measurementOther

    Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.

  • Back-leg-chest muscle strength measurementOther

    An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.

  • Functional performanceOther

    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 capacityOther

    Functional capacity will be evaluated with six minute walk test according to the ATS criteria.

Study groups in NCT05882981
Study groupRoleWhat they receive
Study group22 young adults aged 17-26 years with high femoral anteversion.
Receives: Other: Sit and reach test; Other: Hand grip strength measurement; Other: Back-leg-chest muscle strength measurement; Other: Functional performance; Other: Functional capacity
Control group22 young adults aged 17-26 years with normal femoral anteversion
Receives: Other: Sit and reach test; Other: Hand grip strength measurement; Other: Back-leg-chest muscle strength measurement; Other: Functional performance; Other: Functional capacity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional performance tests

    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).

    Measured: One day

  2. Functional capacity measurement

    Functional capacity will be evaluated with six minute walk test according to the ATS criteria.

    Measured: One day

Secondary outcomes (3)
  1. Sit and reach test

    It will be used to measure the flexibility of the participants.

    Measured: One day

  2. Back-leg-chest muscle strength measurement

    An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.

    Measured: One day

  3. Hand grip strength measurement

    Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.

    Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start20 Oct 2023
  3. Primary completion20 Dec 2023
  4. Study completion14 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05882981
Sponsor's protocol ID
DT-04
Status last verified
Jan 2024
First submitted
8 May 2023
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of High Femoral Anteversion and Muscle Strength, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

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 7 inclusion and 4 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 Jan 2024. 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 Turkey (Türkiye). 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?

Functional performance tests (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in