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

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045014
• Other study ID #: 2021/144
• Status: Recruiting
• Start date: November 30, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2021
• Source: Inonu University
• Contact: Busra CANDIRI
• Phone: +905073780717
• Email: candiri_17[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Vestibular Diseases
• Vestibular Function Disorder
• Visuospatial/Perceptual Abilities

Intervention

Other:
• Balance assessment
Romberg test and one-leg standing test will be used.
• 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.
• Corsi Block Tapping (mobil app)
Spatial memory will be evaluated.
• 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.
• Cobb angle measurement
It will be evaluated with the help of X-ray.
• Scolio Detector (mobil app)
The degree of rotation will be measured with the mobile application called Scolio Detector.

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bigelow RT, Agrawal Y. Vestibular involvement in cognition: Visuospatial ability, attention, executive function, and memory. J Vestib Res. 2015;25(2):73-89. doi: 10.3233/VES-150544. Review. — View Citation

Le Berre M, Guyot MA, Agnani O, Bourdeauducq I, Versyp MC, Donze C, Thévenon A, Catanzariti JF. Clinical balance tests, proprioceptive system and adolescent idiopathic scoliosis. Eur Spine J. 2017 Jun;26(6):1638-1644. doi: 10.1007/s00586-016-4802-z. Epub 2016 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of vestibular dysfunction-1	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
Primary	Visual spatial perception	The mobile application score called Corsi Block Tapping will be recorded.	10 month
Primary	Evaluation of vestibular dysfunction-2	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	Balance assessment-1	Romberg test will be used. Romberg test will be recorded as (+/-) according to the individual standing with eyes closed for 30 seconds.	10 month
Secondary	Navigasyon performansinda	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
Secondary	Quality of life assessment	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
Secondary	Balance assessment-2	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