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Evaluation of Postural Control in Children Using Tetra Axial Posturography (tetrax1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Meir Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Meir Medical Center Identifier:
First received: June 16, 2009
Last updated: October 18, 2010
Last verified: June 2009
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.

Condition Intervention
Normal Children
Other: Evaluation of postural control

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of Postural Control in Children Using Tetra Axial Posturography

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Creation of normal baseline data [ Time Frame: one year ]

Secondary Outcome Measures:
  • evaluation of a new analysis software [ Time Frame: one year ]

Estimated Enrollment: 480
Study Start Date: July 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: normal children
Normal children ages 5-12 years.
Other: Evaluation of postural control
Children will be measured once using a Tetra-aximetric posturography method
Experimental: postural control Other: Evaluation of postural control
Children will be measured once using a Tetra-aximetric posturography method

Detailed Description:
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.

Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00922558

Contact: Reoven Cohen-Raz, Phd 972-52-5402771

Reoven Cohen-Raz Recruiting
Jerusalem, Israel
Contact: Reoven Cohen-Raz, Phd    972-52-5402771   
Sponsors and Collaborators
Meir Medical Center
Principal Investigator: Dan Nemet, MD Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University
  More Information

Responsible Party: Dan Nemet M.D.,, Meir Medical Center Identifier: NCT00922558     History of Changes
Other Study ID Numbers: MeirMc068-09CTIL
Study First Received: June 16, 2009
Last Updated: October 18, 2010

Keywords provided by Meir Medical Center:
tetra-axiametric posturography
postural control
children processed this record on April 28, 2017