NCT04181125

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

November 22, 2019

Last Update Submit

November 21, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Postural control-postural stability

    Computerized test of postural stability with Biodex Balance System

    1 day

  • Postural control-limits of stability

    Computerized test of limits of stability with Biodex Balance System

    1 day

  • Postural control-sensory integration

    Computerized test of sensory integration with Biodex Balance System

    1 day

  • Balance Error Scorring System-BESS

    Clinical evaluation of postural control

    1 day

Study Arms (2)

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.

Other: Biodex Balance SystemOther: 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.

Other: Biodex Balance SystemOther: Balance Error Scoring System (BESS)

Interventions

For the computerized evaluation of postural control, Biodex Balance System will be used.

Children with increased femoral anteversionHealthy children

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

Children with increased femoral anteversionHealthy children

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • History of surgery or BoNT-A for lower extremities
  • Leg length discrepancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Hülya Nilgun Gurses, Prof.

    Bezmialem Vakif University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Department of Physiotheray and Rehabilitation, Bezmialem Vakif University

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 29, 2019

Study Start

April 1, 2019

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations