Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old
Recruitment status was Active, not recruiting
|First Received Date ICMJE||August 30, 2005|
|Last Updated Date||April 26, 2007|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00140699 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old|
|Official Title ICMJE||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 :
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).
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.
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Deaf Children|
|Intervention ICMJE||Behavioral: Balance|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Healthy group :
Sensorineural hearing loss group :
|Ages||6 Years to 14 Years|
|Accepts Healthy Volunteers||Not Provided|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||France|
|NCT Number ICMJE||NCT00140699|
|Other Study ID Numbers ICMJE||2001.264|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hospices Civils de Lyon|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Hospices Civils de Lyon|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP