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Balance Control and Maturation in Normal and Deaf Children Aged from 6 to 14 Years Old - Article


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Clinical Trial: Balance Control and Maturation in Normal and Deaf Children Aged from 6 to 14 Years Old

This study is currently recruiting patients.
Verified by Hospices Civils de Lyon September 2005

Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00140699

Purpose

Balance disorders in children are poorely known, underestimated, and rarely assessed. Technologies to assess balance in children are almost non-existent, apart from a few exceptions. Such technologies are routinely used in adults for some decades, and are of considerable contribution in the diagnosis and treatment of adults balance disorders.

The aim of this study is :

  1. to assess objectively children balance disorders.
  2. to provide technologies suitable for children balance assessement.
  3. to study children balance disorders suffering from sensorineural hearing loss.
Condition Intervention
Deaf children
 Behavior: Balance

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Screening, Longitudinal, Case Control, Prospective Study

Further Study Details: 

Expected Total Enrollment:  240

The inner ear included two sensorineural organs closely linked : the cochlea and the vestibule. With regards to children inner ear affliction, only cochlear function is taken into consideration, whereas balance related to vestibule function is often neglected.

Congenital sensorineural hearing loss is frequent (3/1000 birthes, Martin et al. 1981, Fortum et al. 1997). Furthermore, otitis media is among the most frequent afflictions discovered in small childhood, and Handicaps secondary to sensorineural hearing loss are numerous : language, cognitive disorders, delay according to school and social integration (Joint Commitee on Infant Hearing 1994, Casselbrant et al. 2005, Jung et al. 2005).

In counterpart, children balance disorders are often unknown and underestimated. However, they clinically lead to an evident handicap in case of acute or chronic otitis media (Caselbrant et al. 1995). Balance control involves three sensory systems tightly linked : vision, vestibule, and somesthesia. From the links between vision and vestibule originate the visio-vestibulo and vestibulo-ocular reflexes (VVOR,VOR). Dynamic Posturography (DP) is a technology able to measure each of these sensory inputs involved in balance control by recording sensory organization test (SOT). This technology is available for adults for a few decades but are poorely used in children (Wiener- Vacher et al. 1996, 1998, Casselbrant et al 1995, 2005).

Aims :

1-To assess objectively children balance control (to provide normative data according to the age). 2- to put in place methods to investigate children balance disorders. 3- to study children balance disorders suffering from sensorineural hearing loss.

Methods :

Studied population : two groups of children are involved and compared in this study : 150 healthy children and 150 children suffering from sensorineural hearing loss. Each group is divided into three age groups : 6-8, 8-10, 10-12 years old.

Assessement :

The following parameters are recorded in both groups : VVOR and VOR, SOT on two DP Equitest and Balance Quest. Transient Evoked Otoacoustic Emissions were recorded too in order to prove normal hearing status in the healthy group and hearing loss in the sensorineural hearing loss group.

Eligibility

Ages Eligible for Study:  6 Years   -   14 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Healthy group :

  • Normal neurological status
  • Normal visual status
  • Normal ENT status
  • TEOE present
  • Informed consent aproved and signed

Sensorineural hearing loss group :

  • Normal neurological status
  • Normal visual status
  • Otitis media or endocochlear hearing loss
  • In the case of otitis, flat curve at tympanometry
  • Transmissional aspect at BAERs
  • Informed consent aproved and signed

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00140699

Chantal Ferber-Viart, MD, PhD      33 478 861  Ext. 343    chantal.viart-ferber@chu-lyon.fr

France
      Centre Hospitalier Lyon Sud, Pierre Bénite,  69395,  France; Recruiting
Chantal Ferber-Viart, MD, PhD  33 478 861  Ext. 343    chantal.viart-ferber@chu-lyon.fr 
Chantal Ferber-Viart, MD, PhD,  Principal Investigator

Study chairs or principal investigators

Chantal Ferber-Viart, MD, PhD,  Principal Investigator,  Hospices Civils de Lyon   

More Information

Study ID Numbers:  2001.264
Last Updated:  September 1, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00140699
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06


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