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).
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
- Conditions the study is for
- High Femoral Anteversion, Muscle Strength, Flexibility
- 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.
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".
- Conditions
- High Femoral Anteversion, Muscle Strength, Flexibility, Functional Performance, Functional Capacity
- 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 group | Role | What they receive |
|---|---|---|
| Study group | 22 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 group | 22 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.
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
Functional capacity measurement
Functional capacity will be evaluated with six minute walk test according to the ATS criteria.
Measured: One day
Secondary outcomes (3)
Sit and reach test
It will be used to measure the flexibility of the participants.
Measured: One day
Back-leg-chest muscle strength measurement
An analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength.
Measured: One day
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.
- First posted31 May 2023
- Study start20 Oct 2023
- Primary completion20 Dec 2023
- Study completion14 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Femoral AnteversionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Performance of Young Adults With Increased Femoral Anteversion
- ClinicalTrials.gov ID
- NCT05882981
- Acronym / sponsor ID
- DT-04
- Conditions
- High Femoral Anteversion, Muscle Strength, Flexibility, Functional Performance, Functional Capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 31 May 2023 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Sit and reach test, Other: Hand grip strength measurement, Other: Back-leg-chest muscle strength measurement, Other: Functional performance, Other: Functional capacity22 young adults aged 17-26 years with high femoral anteversion. |
| Control group | – | Other: Sit and reach test, Other: Hand grip strength measurement, Other: Back-leg-chest muscle strength measurement, Other: Functional performance, Other: Functional capacity22 young adults aged 17-26 years with normal femoral anteversion |
Who may qualify
- Ages
- 17 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 22 young adults aged 17-26 years with high femoral anteversion.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Sit and reach testIt will be used to measure the flexibility of the participants. | Other | Control group, Study group |
| Hand grip strength measurementGrip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists. | Other | Control group, Study group |
| Back-leg-chest muscle strength measurementAn analog Back Leg-Chest dynamometer will be used to evaluate general muscle strength. | Other | Control group, Study group |
| Functional performanceSingle-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). | Other | Control group, Study group |
| Functional capacityFunctional capacity will be evaluated with six minute walk test according to the ATS criteria. | Other | Control group, Study group |
Primary outcome
Functional performance tests
Time frame: One day
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 measurement
Time frame: One day
Functional capacity will be evaluated with six minute walk test according to the ATS criteria.
3 secondary outcomes
Sit and reach test
Time frame: One day
Back-leg-chest muscle strength measurement
Time frame: One day
Hand grip strength measurement
Time frame: One day
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 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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?
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.