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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00922558
First received: June 16, 2009
Last updated: October 18, 2010
Last verified: June 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of Postural Control in Children Using Tetra Axial Posturography

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Creation of normal baseline data [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluation of a new analysis software [ Time Frame: one year ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922558

Contacts
Contact: Reoven Cohen-Raz, Phd 972-52-5402771 tetrax50@gmail.com

Locations
Israel
Reoven Cohen-Raz Recruiting
Jerusalem, Israel
Contact: Reoven Cohen-Raz, Phd    972-52-5402771    tetrax50@gmail.com   
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Dan Nemet, MD Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University
  More Information

No publications provided

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

Keywords provided by Meir Medical Center:
tetra-axiametric posturography
postural control
tetrax
children

ClinicalTrials.gov processed this record on November 25, 2014