Scoliosis IdiopathicNCT05045014
Evaluation of Vestibular Dysfunction or Visuospatial Perception in Individuals With Idiopathic Scoliosis
An observational study of Scoliosis Idiopathic and Vestibular Function Disorder, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Vestibular Function Disorder, Visuospatial/Perceptual Abilities
- What is being tested?
- Balance assessment, Unterberger test and Corsi Block Tapping (mobıl app)
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2021to 15 Jun 2022
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals with idiopathic scoliosis and healthy individuals
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu University
Malatya
Busra Candiri, 05073780717, busracandiri@gmail.com
Busra Candiri
About this study
Official title: 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.
Read the 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.
- Being tested
- Balance assessment, Unterberger test, Corsi Block Tapping (mobıl app), Navigation performance, Cobb angle measurement
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance assessmentOther
Romberg test and one-leg standing test will be used.
Unterberger testOther
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 (mobıl app)Other
Spatial memory will be evaluated.
Navigation performanceOther
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 measurementOther
It will be evaluated with the help of X-ray.
Scolio Detector (mobıl app)Other
The degree of rotation will be measured with the mobile application called Scolio Detector.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Balance assessment; Other: Unterberger test; Other: Corsi Block Tapping (mobıl app); Other: Navigation performance; Other: Cobb angle measurement; Other: 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. Receives: Other: Balance assessment; Other: Unterberger test; Other: Corsi Block Tapping (mobıl app); Other: Navigation performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 month
Visual spatial perception
The mobile application score called Corsi Block Tapping will be recorded.
Measured: 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.
Measured: 10 month
Secondary outcomes (4)
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.
Measured: 10 month
Navigasyon performansında
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.
Measured: 10 month
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.
Measured: 10 month
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.
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Nov 2021
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Burcu TALU, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045014
- Sponsor's protocol ID
- 2021/144
- Status last verified
- Nov 2021
- First submitted
- 14 Jul 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26410672Le 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.
PubMed 27844226
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Vestibular Dysfunction or Visuospatial Perception Affected in Individuals With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05045014
- Acronym / sponsor ID
- 2021/144
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 16 Sep 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: Balance assessment, Other: Unterberger test, Other: Corsi Block Tapping (mobıl app), Other: Navigation performance, Other: Cobb angle measurement, Other: Scolio Detector (mobıl app)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. |
| Control group | – | Other: Balance assessment, Other: Unterberger test, Other: Corsi Block Tapping (mobıl app), Other: Navigation performanceRomberg 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. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals with idiopathic scoliosis and healthy individuals
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance assessmentRomberg test and one-leg standing test will be used. | Other | Control group, Patient group |
| Unterberger testDuring 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 | Control group, Patient group |
| Corsi Block Tapping (mobıl app)Spatial memory will be evaluated. | Other | Control group, Patient group |
| Navigation performanceTwo 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 | Control group, Patient group |
| Cobb angle measurementIt will be evaluated with the help of X-ray. | Other | Patient group |
| Scolio Detector (mobıl app)The degree of rotation will be measured with the mobile application called Scolio Detector. | Other | Patient group |
Primary outcome
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.
Visual spatial perception
Time frame: 10 month
The mobile application score called Corsi Block Tapping will be recorded.
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.
4 secondary outcomes
Balance assessment-1
Time frame: 10 month
Navigasyon performansında
Time frame: 10 month
Quality of life assessment
Time frame: 10 month
Balance assessment-2
Time frame: 10 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 26410672Bigelow 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.
- Background: PubMed 27844226Le 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.
- Individual participant dataSharing planned: No
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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.
Burcu TALU principal investigator
Inonu University
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 Scoliosis Idiopathic and Vestibular Function Disorder, run by Inonu University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Busra CANDIRI (+905073780717, candiri_17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of vestibular dysfunction-1 (time frame: 10 month). 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?
On the ClinicalTrials.gov record for NCT05045014, which also lists 2 linked publications.
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 14 Jan 2022.