- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181125
"Evaluation of Postural Control in Children With Increased Femoral Anteversion"
November 21, 2020 updated by: Deniz Tuncer, Bezmialem Vakif University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Bezmialem Vakif University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 15 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of surgery or BoNT-A for lower extremities
- Leg length discrepancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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For the computerized evaluation of postural control, Biodex Balance System will be used.
For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
|
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.
|
For the computerized evaluation of postural control, Biodex Balance System will be used.
For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural control-postural stability
Time Frame: 1 day
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Computerized test of postural stability with Biodex Balance System
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1 day
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Postural control-limits of stability
Time Frame: 1 day
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Computerized test of limits of stability with Biodex Balance System
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1 day
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Postural control-sensory integration
Time Frame: 1 day
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Computerized test of sensory integration with Biodex Balance System
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1 day
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Balance Error Scorring System-BESS
Time Frame: 1 day
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Clinical evaluation of postural control
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hülya Nilgun Gurses, Prof., Bezmialem Vakif University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2019
Primary Completion (ACTUAL)
September 1, 2020
Study Completion (ACTUAL)
November 1, 2020
Study Registration Dates
First Submitted
November 22, 2019
First Submitted That Met QC Criteria
November 27, 2019
First Posted (ACTUAL)
November 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 21, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- DT-01
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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