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Evaluation of Postural Control in Children Using Tetra Axial Posturography

NCT ID: NCT00922558

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of electronic signals emitted by four footplates, one for each heel and toe, respectively. These are sensitive to vertical pressure produced by a subject standing straight but in various positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields additional parameters not obtained by the traditional monoplate stabilometers, namely, weight-distribution patterns and correlation among six combinations of paired outputs from the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric synchronizations). Comparing age-matched learning disabled, mentally retarded, autistic, and hearing impaired (with and without labyrinthine hypofunction) with normal children, significant and clinically meaningful differences were detected between the Tetra-ataxiametric measures of stability, interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and synchronizations of toe parts. The same parameters correlated significantly with cognitive school readiness in normal populations. While the stability and spectral quotients show significant developmental changes, weight distribution and toe synchronisations are stable from 5 years onwards. The method is suitable for young subjects and attractive to children who may ordinarily be reluctant to cooperate, such as the autistic ones. The equipment is portable and tests can be conveniently carried out in a child's familiar educational setting.

Detailed Description

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Recently a new pediatric software was introduced for the TETRAX device. The goal of the present study is to create normative data for children starting at preschool age using the newly developed software. Four hundred and 80 children between the ages of 5 and 12 years old will be examined following informed consent from the children and their legal guardian.

Conditions

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Normal Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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normal children

Normal children ages 5-12 years.

Group Type NO_INTERVENTION

Evaluation of postural control

Intervention Type OTHER

Children will be measured once using a Tetra-aximetric posturography method

postural control

Group Type EXPERIMENTAL

Evaluation of postural control

Intervention Type OTHER

Children will be measured once using a Tetra-aximetric posturography method

Interventions

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Evaluation of postural control

Children will be measured once using a Tetra-aximetric posturography method

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 5-12 years
* healthy

Exclusion Criteria

* children with known disturbances in bone, muscle of nervous systems
* children using medications that may cause problems in balance or coordination
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Meir Medical Center

Principal Investigators

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Dan Nemet, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University

Locations

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Reoven Cohen-Raz

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Reoven Cohen-Raz, Phd

Role: CONTACT

[email protected]
972-52-5402771

Facility Contacts

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Reoven Cohen-Raz, Phd

Role: primary

[email protected]
972-52-5402771

Other Identifiers

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MeirMc068-09CTIL

Identifier Type: -

Identifier Source: org_study_id