Evaluation of Vestibular Dysfunction or Visuospatial Perception in Individuals With Idiopathic Scoliosis

January 13, 2022 updated by: Burcu Talu, Inonu University

Is Vestibular Dysfunction or Visuospatial Perception Affected in Individuals With Idiopathic Scoliosis

This study was planned to investigate whether there is a visual-spatial perception disorder in individuals with idiopathic scoliosis and also to reveal its dependent/independent relationship with vestibular dysfunction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Vestibular dysfunction is thought to be associated with the etiology of patients with idiopathic scoliosis. However, there is limited data on this in the literature. However, visuospatial ability has been evaluated in the literature regarding vestibular dysfunction independent of scoliosis. In the study, it was first requested to investigate vestibular dysfunction in patients with scoliosis. However, as far as is known, there is no study in the literature on visuospatial perception investigated for vestibular dysfunction in patients with scoliosis. This study was planned to investigate whether there is a disorder related to visuospatial perception and to reveal its dependent/independent relationship with vestibular dysfunction. Based on the studies, it is planned to evaluate visuospatial (visual-spatial) perception performance in the presence/absence of vestibular dysfunction in individuals with idiopathic scoliosis. The hypothesis of the study is that vestibular function and related visual-spatial perception may be affected in individuals with idiopathic scoliosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Malatya, Turkey
        • Recruiting
        • Inonu University
        • Contact:
        • Principal Investigator:
          • Busra Candiri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with idiopathic scoliosis and healthy individuals

Description

Inclusion Criteria:

For the patient and control group;

  • Those who do not have any other joint deformity,
  • Those between the ages of 10-25,
  • Individuals with good mental status Only for the experimental group
  • Individuals diagnosed with idiopathic scoliosis,
  • Those who have not received physiotherapy and rehabilitation for idiopathic scoliosis in the last 6 months,

Exclusion Criteria:

  • Those with severe hearing and visual impairment, any neurological, orthopedic, metabolic, rheumatological disorders other than idiopathic scoliosis
  • Other types of scoliosis,
  • Individuals with benign paroxysmal positional vertigo, meniere, primary pathologies of the ear and a history of serious infection (ear, internal organ) will be excluded
  • In healthy individuals, shoulder height difference during scanning, visual impairment, dizziness in the last 1 year, glasses wearers and individuals with a history of middle ear infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient group
Romberg test and single leg standing test will be used in balance assessment. The presence of vestibular dysfunction will be evaluated with the Utenberger test. Under the name of visual-spatial perception, spatial memory will be evaluated with the mobile application called Corsi Block Tapping, and navigation performance will be evaluated with the triangle completion task. In addition, X-ray images taken during routine follow-ups will be used to determine the location, type of curvature and Cobb angle of the scoliosis. The degree of rotation will be measured with a mobile application called Scoliodetector. Quality of life is planned to be evaluated with the Scoliosis Research Society-22 questionnaire.
Other: Balance assessment
Romberg test and one-leg standing test will be used.
Other: Unterberger test
During 50 steps, he will count in place with 45 degrees of hip flexion, and after 50 steps, the angle of rotation between the first position and the final position of the right foot will be measured with the help of a goniometer and the displacement distance.
Other: Corsi Block Tapping (mobıl app)
Spatial memory will be evaluated.
Other: Navigation performance
Two triangles (one equilateral, one oblique triangle, at 30°, 60° and 90° angles respectively) with route segment lengths between 150 and 300 cm will be marked on the floor and the participants will be asked to complete the task with their eyes closed. The final deviation amount will be recorded.
Other: Cobb angle measurement
It will be evaluated with the help of X-ray.
Other: Scolio Detector (mobıl app)
The degree of rotation will be measured with the mobile application called Scolio Detector.
Control group
Romberg test and single leg standing test will be used in balance assessment. The presence of vestibular dysfunction will be evaluated with the Utenberger test. Under the name of visual-spatial perception, spatial memory will be evaluated with the mobile application called Corsi Block Tapping, and navigation performance will be evaluated with the triangle completion task.
Other: Balance assessment
Romberg test and one-leg standing test will be used.
Other: Unterberger test
During 50 steps, he will count in place with 45 degrees of hip flexion, and after 50 steps, the angle of rotation between the first position and the final position of the right foot will be measured with the help of a goniometer and the displacement distance.
Other: Corsi Block Tapping (mobıl app)
Spatial memory will be evaluated.
Other: Navigation performance
Two triangles (one equilateral, one oblique triangle, at 30°, 60° and 90° angles respectively) with route segment lengths between 150 and 300 cm will be marked on the floor and the participants will be asked to complete the task with their eyes closed. The final deviation amount will be recorded.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of vestibular dysfunction-1
Time Frame: 10 month
Unterberger test will be used. Subjects will close their eyes and measure displacement in 50 steps with their shoulders flexed 90 degrees and arms extended forward.
10 month
Visual spatial perception
Time Frame: 10 month
The mobile application score called Corsi Block Tapping will be recorded.
10 month
Evaluation of vestibular dysfunction-2
Time Frame: 10 month
Unterberger test will be used. Subjects will close their eyes and with their shoulders flexed 90 degrees and arms extended forward, the amount of rotation in 50 steps will be measured as an angle.
10 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Balance assessment-1
Time Frame: 10 month
Romberg test will be used. Romberg test will be recorded as (+/-) according to the individual standing with eyes closed for 30 seconds.
10 month
Navigasyon performansında
Time Frame: 10 month
Two triangles (one equilateral, one oblique triangle, at 30°, 60° and 90° angles respectively) with tracktrack lengths between 150 and 300 cm will be marked on the floor and the participants will be asked to complete the task with their eyes closed. The final deviation amount will be recorded.
10 month
Quality of life assessment
Time Frame: 10 month
The SRS-22r is a patient-reported outcome instrument and has a range from 1 (worst) to 5 (best). It contains 22 questions covering five domains: function, pain, self-image, mental health (each with 5 items), and satisfaction with treatment (2 items) and each item is scored from 1 to 5.
10 month
Balance assessment-2
Time Frame: 10 month
One-leg standing test will be used. The time to stand on one foot will be recorded in seconds with eyes open/closed and on hard/soft ground.
10 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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