- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07356999
Characterization of Visual Perception Impairments in Patients With Idiopathic Scoliosis (EYAIS)
Characterization of Visual Perception Alterations in Patients With Idiopathic Scoliosis: Towards a Theory of Perceptual Imbalance
Scoliosis is more than just a curve in the spine; it is a complex, 3D twisting of the backbone. While it can be caused by birth defects or tumors, the most common type-idiopathic scoliosis-appears in healthy teenagers for no clearly known reason.
The Theory of Balance Researchers believe that scoliosis might actually be caused by a "glitch" in how the body stays upright. Instead of the spine curving on its own, the curve might be the body's way of compensating for a poor sense of balance.
To stay balanced, the human brain relies on three main "inputs":
- The Vestibular System: Located in the inner ear (detects movement).
- Proprioception: The body's "inner map" (sensing where your limbs are).
- Vision: Seeing the world around you to stay oriented.
The Goal of the Study Even though humans rely heavily on their eyes to stay balanced, the role of vision in scoliosis has not been studied very much.
This experiment aims to test the hypothesis that teenagers with scoliosis have trouble processing visual information to maintain their posture. By using advanced motion analysis, researchers want to see if a "misunderstanding" of visual cues is contributing to the spinal deformity.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lyon, France, 69005
- Recruiting
- Centre Médico chirurgical de Réadaptation des Massues
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Contact:
- Julie Rozaire, PhD
- Phone Number: +33 4 72 38 11 43
- Email: lab.massues@croix-rouge.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Group Scoliosis:
- Girls or boys aged 11 to 18 inclusive.
- Patients with progressive idiopathic scoliosis
- Candidates for either orthopedic (brace) or surgical (arthrodesis correction) treatment for which a pre-therapeutic multimodal assessment is planned.
Control group:
- Girls or boys aged 11 to 18 inclusive.
Exclusion Criteria:
The following individuals will not be included:
- Individuals with another musculoskeletal disorder.
- Individuals with a neurosensory disorder that may affect the balance of the trunk or lower limbs.
- Individuals with uncorrected visual perception disorders (visual check within 12 months prior to the examination).
- Lack of consent from the subject.
- Lack of consent from legal representatives.
- Failure to understand the instructions for performing the tests.
In addition, for the control group:
- Suffering from scoliosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Vertical Perception Assessment
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Researchers use motion capture to track exactly how a patient's body moves and shifts in response to different environments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Margin of Dynamic Stability
Time Frame: At enrollment
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This measures how close a person is to losing their balance while moving.
It calculates the distance between where the body's weight is moving and the edge of the person's "footprint" (base of support).
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At enrollment
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Center of Pressure
Time Frame: At enrollment
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The point on the ground where the most weight is being concentrated.
Tracking how much this point "wobbles" or shifts shows how hard the body is working to stay upright.
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At enrollment
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Extrapolated Center of Mass
Time Frame: At enrollment
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A calculation that looks at both the position of the body and its velocity.
It helps researchers predict if the person's momentum is about to carry them off-balance.
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At enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Base of Support
Time Frame: At enrollment
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The total area on the ground occupied by the feet.
A wider BoS often suggests the subject is trying to create a "wider stance" to feel more stable.
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At enrollment
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Visual Field Perception
Time Frame: At enrollment
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The "Distance Error."
Using a joystick, the patient tries to place a 3D avatar exactly halfway between two other figures.
The difference between the true middle and where the patient thinks the middle is reveals if their depth perception is distorted.
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At enrollment
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Subjective Visual Vertical
Time Frame: At enrollment
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Angular Error.
A glowing line is tilted on a screen, and the patient must tell the operator how to rotate it until it is perfectly vertical.
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At enrollment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025_10_EYAIS_RIPH2
- 2025-A01301-48 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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