NCT05045014

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

January 14, 2022

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

July 14, 2021

Last Update Submit

January 13, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • Visual spatial perception

    The mobile application score called Corsi Block Tapping will be recorded.

    10 month

  • 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 Outcomes (4)

  • Balance assessment-1

    10 month

  • Navigasyon performansında

    10 month

  • Quality of life assessment

    10 month

  • Balance assessment-2

    10 month

Study Arms (2)

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 assessmentOther: Unterberger testOther: Corsi Block Tapping (mobıl app)Other: Navigation performanceOther: Cobb angle measurementOther: Scolio Detector (mobıl app)

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 assessmentOther: Unterberger testOther: Corsi Block Tapping (mobıl app)Other: Navigation performance

Interventions

Romberg test and one-leg standing test will be used.

Control groupPatient group

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.

Control groupPatient group

Spatial memory will be evaluated.

Control groupPatient group

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.

Control groupPatient group

It will be evaluated with the help of X-ray.

Patient group

The degree of rotation will be measured with the mobile application called Scolio Detector.

Patient group

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals with idiopathic scoliosis and healthy individuals

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 26410672BACKGROUND
  • Le Berre M, Guyot MA, Agnani O, Bourdeauducq I, Versyp MC, Donze C, Thevenon 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.

    PMID: 27844226BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Burcu TALU

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 14, 2021

First Posted

September 16, 2021

Study Start

November 30, 2021

Primary Completion

April 15, 2022

Study Completion

June 15, 2022

Last Updated

January 14, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations