Idiopathic ScoliosisNCT04714632
Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis
An observational study of Idiopathic Scoliosis and Vestibular Abnormality, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis, Vestibular Abnormality
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2018to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with Idiopathic scoliosis
Who may be able to join
- idiopathic scoliosis
Who cannot join
- operation of the spine
- neurological disease
- hearing problems
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Rehabilitation and Sports Medicine, University Hospital Motol
Prague, 15006
About this study
Official title: Vestibular Function in Adolescents With Idiopathic Scoliosis
The purpose of this study was to evaluate vestibular function in children with idiopathic scoliosis as a possible cause of etiopathogenesis of its diagnose.
- Conditions
- Idiopathic Scoliosis, Vestibular Abnormality
- Keywords
- idiopathic scoliosis, subjective visual vertical, vestibular evoked myogenic potentials, posturography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with idiopathic scoliosis | Adolescent between 10-18y with diagnosing idiopathic scoliosis | |
| Healthy children | Healthy children between 10-18y without any orthopedics problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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°
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Nov 2018
- Primary completion1 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klara Kucerova, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714632
- Sponsor's protocol ID
- 260119
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Function in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04714632
- Acronym / sponsor ID
- 260119
- Conditions
- Idiopathic Scoliosis, Vestibular Abnormality
- Keywords
- idiopathic scoliosis, subjective visual vertical, vestibular evoked myogenic potentials, posturography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate vestibular function in children with idiopathic scoliosis as a possible cause of etiopathogenesis of its diagnose.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with idiopathic scoliosis | – | –Adolescent between 10-18y with diagnosing idiopathic scoliosis |
| Healthy children | – | –Healthy children between 10-18y without any orthopedics problems |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with Idiopathic scoliosis
Key inclusion criteria (1 listed)
- idiopathic scoliosis
Key exclusion criteria (3 listed)
- operation of the spine
- neurological disease
- hearing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
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°
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis and Vestibular Abnormality, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular evoked myogenic potentials (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.