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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Biodex Balance System
For the computerized evaluation of postural control, Biodex Balance System will be used.
Other: Balance Error Scoring System (BESS)
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.
Other: Biodex Balance System
For the computerized evaluation of postural control, Biodex Balance System will be used.
Other: Balance Error Scoring System (BESS)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postural control-postural stability
Time Frame: 1 day
Computerized test of postural stability with Biodex Balance System
1 day
Postural control-limits of stability
Time Frame: 1 day
Computerized test of limits of stability with Biodex Balance System
1 day
Postural control-sensory integration
Time Frame: 1 day
Computerized test of sensory integration with Biodex Balance System
1 day
Balance Error Scorring System-BESS
Time Frame: 1 day
Clinical evaluation of postural control
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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