- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04200924
Evaluation of Postural Control in Children With Idiopathic Toe Walking
July 19, 2022 updated by: Deniz Tuncer, Bezmialem Vakif University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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).
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
6 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
16 children with idiopathic toe walking 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:
- 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 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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with idiopathic toe walking
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.
|
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.
|
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
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hulya N 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)
June 1, 2019
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
December 13, 2019
First Submitted That Met QC Criteria
December 13, 2019
First Posted (Actual)
December 16, 2019
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- DT-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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