NCT04714632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

January 14, 2021

Last Update Submit

January 15, 2021

Conditions

Idiopathic ScoliosisVestibular Abnormality

Keywords

idiopathic scoliosissubjective visual verticalvestibular evoked myogenic potentialsposturography

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Children with idiopathic scoliosis

Adolescent between 10-18y with diagnosing idiopathic scoliosis

Healthy children

Healthy children between 10-18y without any orthopedics problems

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with Idiopathic scoliosis

You may qualify if:

  • idiopathic scoliosis

You may not qualify if:

  • operation of the spine
  • neurological disease
  • hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Sports Medicine, University Hospital Motol

Prague, 15006, Czechia

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of science

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 19, 2021

Study Start

November 1, 2018

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

CZ(1)