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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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 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

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
Intervention / Treatment
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

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

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

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)

November 30, 2021

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

June 15, 2022

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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