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NCT04714632 Clinical Trial

Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis

Idiopathic Scoliosis Clinical Trial

Official title:
Vestibular Function in Adolescents With Idiopathic Scoliosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04714632
Other study ID # 260119
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date April 1, 2020

Study information
Verified date January 2021
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate vestibular function in children with idiopathic scoliosis as a possible cause of etiopathogenesis of its diagnose.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - idiopathic scoliosis Exclusion Criteria: - operation of the spine - neurological disease - hearing problems

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Czechia Department of Rehabilitation and Sports Medicine, University Hospital Motol Prague

Sponsors (1)
Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vestibular evoked myogenic potentials To evaluate the results of vestibular evoked myogenic potentials we used the latency (ms) and the amplitude (µV) of the positive wave (P13) and the negative wave (N23) up to 6 months
Primary Posturography Posturography was measured in 6 different sensory conditions. The posturographic parameters of center of pressure were measured for this study. up to 6 months
Primary Perception of subjective visual vertical We measured perception of subjective visual vertical (SVV) in static and dynamic conditions. Each participant completed a total of six trials for static SVV and twelve trials for dynamic SVV, in six trials the optokinetic background rotated clockwise and in six trials counterclockwise. Norms for static conditions are ±2° and for dynamic conditions ±4° up to 6 months
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