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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04714632
Recruitment Status : Completed
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Klara Kucerova, Charles University, Czech Republic

Study Description
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Brief 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.

Condition or disease
Idiopathic Scoliosis Vestibular Abnormality

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vestibular Function in Adolescents With Idiopathic Scoliosis
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Groups and Cohorts
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Group/Cohort
Children with idiopathic scoliosis
Adolescent between 10-18y with diagnosing idiopathic scoliosis
Healthy children
Healthy children between 10-18y without any orthopedics problems


Outcome Measures
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Primary Outcome Measures :
  1. Vestibular evoked myogenic potentials [ Time Frame: up to 6 months ]
    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)

  2. Posturography [ Time Frame: up to 6 months ]
    Posturography was measured in 6 different sensory conditions. The posturographic parameters of center of pressure were measured for this study.

  3. Perception of subjective visual vertical [ Time Frame: up to 6 months ]
    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°


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children with Idiopathic scoliosis
Criteria

Inclusion Criteria:

  • idiopathic scoliosis

Exclusion Criteria:

  • operation of the spine
  • neurological disease
  • hearing problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714632


Locations
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Czechia
Department of Rehabilitation and Sports Medicine, University Hospital Motol
Prague, Czechia, 15006
Sponsors and Collaborators
Charles University, Czech Republic
More Information
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Responsible Party: Klara Kucerova, Master of science, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT04714632    
Other Study ID Numbers: 260119
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klara Kucerova, Charles University, Czech Republic:
idiopathic scoliosis
subjective visual vertical
vestibular evoked myogenic potentials
posturography
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases