Evaluation of Postural Control in Children Using Tetra Axial Posturography

NCT00922558 | Unknown DMC

• 1 other identifier: MeirMc068-09CTIL
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal Children

Keywords

tetra-axiametric posturography; postural control; tetrax; children

Outcome Measures

Primary Outcomes (1)

• Creation of normal baseline data

  one year

Secondary Outcomes (1)

• evaluation of a new analysis software

  one year

Study Arms (2)

normal children

NO INTERVENTION

Normal children ages 5-12 years.

Other: Evaluation of postural control

postural control

EXPERIMENTAL

Other: Evaluation of postural control

Interventions

Evaluation of postural control OTHER

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

normal children; postural control

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 5-12 years
• healthy

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Reoven Cohen-Raz

Jerusalem, Israel

RECRUITING

Study Officials

• Dan Nemet, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reoven Cohen-Raz, Phd

CONTACT

972-52-5402771; tetrax50@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 19, 2010

Record last verified: 2009-06

Locations

IL (1)