Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00140699
First received: August 30, 2005
Last updated: April 26, 2007
Last verified: April 2007

August 30, 2005
April 26, 2007
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Complete list of historical versions of study NCT00140699 on ClinicalTrials.gov Archive Site
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Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old
Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old

Balance disorders in children are poorly 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.

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 births, 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-vestibular 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 poorly 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.

Assessment:

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.

Observational
Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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Deaf Children
Behavioral: Balance
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
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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
Both
6 Years to 14 Years
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Contact information is only displayed when the study is recruiting subjects
France
 
NCT00140699
2001.264
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Hospices Civils de Lyon
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Principal Investigator: Chantal Ferber-Viart, MD, PhD Hospices Civils de Lyon
Hospices Civils de Lyon
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP