Evaluation of Postural Control in Children Using Tetra Axial Posturography (tetrax1)
Recruitment status was Recruiting
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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 |
- Creation of normal baseline data [ Time Frame: one year ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Reoven Cohen-Raz, Phd | 972-52-5402771 | tetrax50@gmail.com |
| Israel | |
| Reoven Cohen-Raz | Recruiting |
| Jerusalem, Israel | |
| Contact: Reoven Cohen-Raz, Phd 972-52-5402771 tetrax50@gmail.com | |
| 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 May 21, 2013