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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04200924
Other study ID # DT-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date May 1, 2022

Study information

Verified date July 2022
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System), which is reported to be a reliable and valid instrument for detecting changes in balance and postural control in the literature.


Description:

Idiopathic toe walking (ITW) is a term used to describe the condition in which children walk with a toe-toe gait pattern in the absence of any known cause. When the literature is examined, it is reported that a possible neuromechanism of idiopathic toe walking is related to postural disorder and a deterioration of sensory information coming from the proprioceptive, vestibular, visual and / or tactile systems. 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. Although there are few studies showing the possible relationship, no studies have been found to evaluate postural control by computerized posturography in these children. In this study, we aimed to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System).


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 15 Years
Eligibility Inclusion Criteria: - Having the diagnosis of idiopathic toe walking - No contact with the heel in the initial contact phase of the gait - Presence of bilateral toe walking gait - Normal neurological and orthopedic examination results - Achievement of independent walking before 18 months - Absence of pervasive developmental disorder or autism Exclusion Criteria: - A history of BoNT-A or surgery in the last 6 months - Presence of 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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