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
  Purpose

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.

Condition Intervention
Deaf Children
Behavioral: Balance

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Estimated Enrollment: 240
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 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
  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: NCT00140699

Locations
France
Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69395
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Chantal Ferber-Viart, MD, PhD Hospices Civils de Lyon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140699     History of Changes
Other Study ID Numbers: 2001.264
Study First Received: August 30, 2005
Last Updated: April 26, 2007
Health Authority: France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:
Children, Hearing loss, Balance control, Sensory inputs

ClinicalTrials.gov processed this record on July 24, 2014