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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04181125
Other study ID # DT-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date November 1, 2020

Study information

Verified date November 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. We aimed to evaluate postural control in children with increased femoral anteversion using computerized dynamic posturography (Biodex Balance System).


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).


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 15 Years
Eligibility 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 Design


Intervention

Other:
Biodex Balance System
For the computerized evaluation of postural control, Biodex Balance System will be used.
Balance Error Scoring System (BESS)
For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postural control-postural stability Computerized test of postural stability with Biodex Balance System 1 day
Primary Postural control-limits of stability Computerized test of limits of stability with Biodex Balance System 1 day
Primary Postural control-sensory integration Computerized test of sensory integration with Biodex Balance System 1 day
Primary Balance Error Scorring System-BESS Clinical evaluation of postural control 1 day
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