Femoral AnteversionNCT04181125
"Evaluation of Postural Control in Children With Increased Femoral Anteversion"
An observational study of Femoral Anteversion and Gait Disorders in Children, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The relationship between increased femoral anteversion and postural control in healthy children has not been studied in the current literature. To our knowledge there is no study to evaluate postural control in children with increased femoral anteversion by computerized posturography. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Anteversion, Gait Disorders in Children, Postural Control
- What is being tested?
- Biodex Balance System and Balance Error Scoring System (BESS)
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Nov 2020
- How long will I take part?
- 1 Day
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 16 children with bilateral increased femoral anteversion aged 6-15 years followed by Bezmialem Vakıf University Department of Orthopedics and Traumatology. 16 healthy volunteers aged 6-15 years will be included in the control group.
Who may be able to join
- Diagnosed as bilateral increased femoral anteversion
- No history of neurological, psychiatric diseases
- Lack of intellectual disability to prevent evaluation and treatment participation
- No participation in any physiotherapy program in the last six months
- Written permission from the parents for participate in the study
Who cannot join
- History of surgery or BoNT-A for lower extremities
- Leg length discrepancy
Trial locations and contacts
1 site in 1 country.
About this study
The relationship between increased femoral anteversion and postural control in healthy children has not been studied in the current literature. To our knowledge there is no study to evaluate postural control in children with increased femoral anteversion by computerized posturography. We aimed to evaluate postural control in children with increased femoral anteversion using computerized dynamic posturography (Biodex Balance System).
Read the detailed description
Femoral anteversion is defined as the angle formed by the femoral condyles plane (bicondylar plane) and a plane passing through the center of the neck and femoral head. Toe-in-gait pattern may be due to foot deformity (metatarsus adductus) and / or abnormal transverse alignment of long bones (tibial torsion and / or increased femoral anteversion). Transverse plane deviations are frequently seen in infants and usually improve with typical physiological growth mechanisms. Persistent transverse plan disorder may lead to gait dysfunction. The most important function of the posture is to maintain the balance during the initiation and continuation of the movement. Postural control regulates maintaining the balance and keeping the center of gravity within the body's stability limits. It includes resistance to gravity forces and mechanical support during movement. Postural control is an integral part of achieving targeted action. To our knowledge the relationship between increased femoral anteversion and postural control in healthy children has not been studied in the current literature. Postural control in children with increased femoral anteversion was evaluated by computerized posturography. In this study, we aimed to evaluate postural control in children with increased femoral anteversion using computerized dynamic posturography (Biodex Balance System).
- Conditions
- Femoral Anteversion, Gait Disorders in Children, Postural Control, Postural Stability, Balance
- Being tested
- Biodex Balance System, Balance Error Scoring System (BESS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex Balance SystemOther
For the computerized evaluation of postural control, Biodex Balance System will be used.
Balance Error Scoring System (BESS)Other
For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Children with increased femoral anteversion | After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. Receives: Other: Biodex Balance System; Other: Balance Error Scoring System (BESS) | |
| Healthy children | After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. Receives: Other: Biodex Balance System; Other: Balance Error Scoring System (BESS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control-postural stability
Computerized test of postural stability with Biodex Balance System
Measured: 1 day
Postural control-limits of stability
Computerized test of limits of stability with Biodex Balance System
Measured: 1 day
Postural control-sensory integration
Computerized test of sensory integration with Biodex Balance System
Measured: 1 day
Balance Error Scorring System-BESS
Clinical evaluation of postural control
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Apr 2019
- Primary completion1 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral AnteversionStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
- Investigators
- Hülya Nilgun Gurses, Prof., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181125
- Sponsor's protocol ID
- DT-01
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Postural Control in Children With Increased Femoral Anteversion"
- ClinicalTrials.gov ID
- NCT04181125
- Acronym / sponsor ID
- DT-01
- Conditions
- Femoral Anteversion, Gait Disorders in Children, Postural Control, Postural Stability, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 29 Nov 2019 (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.
The relationship between increased femoral anteversion and postural control in healthy children has not been studied in the current literature. To our knowledge there is no study to evaluate postural control in children with increased femoral anteversion by computerized posturography. We aimed to evaluate postural control in children with increased femoral anteversion using computerized dynamic posturography (Biodex Balance System).
Detailed description
Femoral anteversion is defined as the angle formed by the femoral condyles plane (bicondylar plane) and a plane passing through the center of the neck and femoral head. Toe-in-gait pattern may be due to foot deformity (metatarsus adductus) and / or abnormal transverse alignment of long bones (tibial torsion and / or increased femoral anteversion). Transverse plane deviations are frequently seen in infants and usually improve with typical physiological growth mechanisms. Persistent transverse plan disorder may lead to gait dysfunction. The most important function of the posture is to maintain the balance during the initiation and continuation of the movement. Postural control regulates maintaining the balance and keeping the center of gravity within the body's stability limits. It includes resistance to gravity forces and mechanical support during movement. Postural control is an integral part of achieving targeted action. To our knowledge the relationship between increased femoral anteversion and postural control in healthy children has not been studied in the current literature. Postural control in children with increased femoral anteversion was evaluated by computerized posturography. In this study, we aimed to evaluate postural control in children with increased femoral anteversion using computerized dynamic posturography (Biodex Balance System).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with increased femoral anteversion | – | Other: Biodex Balance System, Other: Balance Error Scoring System (BESS)After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. |
| Healthy children | – | Other: Biodex Balance System, Other: Balance Error Scoring System (BESS)After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 16 children with bilateral increased femoral anteversion aged 6-15 years followed by Bezmialem Vakıf University Department of Orthopedics and Traumatology. 16 healthy volunteers aged 6-15 years will be included in the control group.
Key inclusion criteria (5 listed)
- Diagnosed as bilateral increased femoral anteversion
- No history of neurological, psychiatric diseases
- Lack of intellectual disability to prevent evaluation and treatment participation
- No participation in any physiotherapy program in the last six months
- Written permission from the parents for participate in the study
Key exclusion criteria (2 listed)
- History of surgery or BoNT-A for lower extremities
- Leg length discrepancy
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 |
|---|---|---|
| Biodex Balance SystemFor the computerized evaluation of postural control, Biodex Balance System will be used. | Other | Children with increased femoral anteversion, Healthy children |
| Balance Error Scoring System (BESS)For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used. | Other | Children with increased femoral anteversion, Healthy children |
Primary outcome
Postural control-postural stability
Time frame: 1 day
Computerized test of postural stability with Biodex Balance System
Postural control-limits of stability
Time frame: 1 day
Computerized test of limits of stability with Biodex Balance System
Postural control-sensory integration
Time frame: 1 day
Computerized test of sensory integration with Biodex Balance System
Balance Error Scorring System-BESS
Time frame: 1 day
Clinical evaluation of postural control
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 24 Nov 2020.
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.
Hülya Nilgun Gurses, Prof. study director
Bezmialem Vakif University
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 Femoral Anteversion and Gait Disorders in Children, 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 5 inclusion and 2 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 24 Nov 2020. 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?
Postural control-postural stability (time frame: 1 day). The study lists 4 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 24 Nov 2020.