Investigating Proprioceptive Impairment in Adolescents With Idiopathic Scoliosis (AIS) (SCOLIO-PROPRIO)

NCT07208929 | Not Yet Recruiting

• 1 other identifier: 2025-A00864-45
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventionnal study is to learn if teenagers who have severe scoliosis (a curvature of the spine) have trouble sensing their body's position in space (this sense is called proprioception), which are directly linked to abnormalities in the part of the brain that controls movement and/or caused by the muscles on each side of the spine not being the same size or not developing in the same way. The main question the investigators aim to answer are :

• Do adolescents with severe scoliosis have problems with their sense of body position (proprioception)?
• If so, are these proprioceptive issues linked to specific problems in the part of the brain that controls movement?
• Are these proprioceptive issues also possibly linked to an uneven muscle structure on either side of the spinal curve? Researchers will compare the part of the brain that controls movement (ensorimotor brain network) of healthy subjects to that of the participants that will enroll in this study. Participants will only have to do one more MRI that is not included in the routine of clinical management of scoliosis before surgery. Data will also be retrieved from clinical practice Participants will answer questionnaires after the day of the surgery

Conditions

Scoliosis Idiopathic Adolescent

Outcome Measures

Primary Outcomes (1)

• Correlation between scoliosis and structural brain alteration as assed by dynamic proprioception test and MRI

  Values of fractional anisotropy (FA) in the corpus callosum and interhemispheric tracts connecting the somatosensory and motor cortices will be compared between the 2 groups of participants \- The differences found between the two groups (patients versus control) will be correlated to the proprioceptive performances in the patient group as assed by motion illusion amplitude index

  One day before surgery

Secondary Outcomes (5)

• Resting state functional connectivity (rs-FC) alteration in AIS assed by MRI

  One day before surgery

• Correlation between Resting-State Functional Connectivity (z-score) as assessed from brain MRI's and Proprioceptive Performance as assessed by measuring the Reproduced Leg Extension Amplitude in degres (°)

  Day before surgery

• Correlation between scoliosis gravity as assessed by the cobb angle (°) with previous MRI's and propriovceptive performance as assessed by measuring the Reproduced Leg Extension Amplitude in degres (°) and the quantified gait analysis (°)

  One day before surgery

• Analysis of scores on body perception as assed by the BESAA

  From day one after surgery to 14 day after surgery

• Physical activity as assessed by the Physical Effort Scale (PES) correlated with cobb angle

  From day one after surgery to 14 day after surgery

Study Arms (2)

Patients with Adolescent Idiopathic Scoliosis

EXPERIMENTAL

Radiation: MRI

Healthy subjects

NO INTERVENTION

External control arm of 30 healthy volounteers from the Human Connectome project from where MRI images will be retrieved.

Interventions

MRI RADIATION

Brain and Spinal Cord MRI

Patients with Adolescent Idiopathic Scoliosis

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents diagnosed with Adolescent Idiopathic Scoliosis (AIS) and followed in the pediatric orthopedic surgery department, scheduled to undergo spinal fusion surgery (arthrodesis)
• No history or clinical signs of neurological disorders
• Aged between 10 and 18 years
• Written informed consent obtained from both the adolescent and their legal guardians (parents)
• Control Group only: Participants will be selected from open-access neuroimaging databases, matched to the patient group by age and sex.

You may not qualify if:

• Presence of any other clinically significant condition that could be associated with spinal deformity
• Insufficient proficiency in French to understand the informed consent form
• Current treatment with psychotropic medication
• Ongoing pregnancy or breastfeeding
• Subject under legal or judicial supervision
• Contraindications to brain MRI (including: pacemaker; electrically, magnetically, or mechanically activated implants; surgical clips; metallic sutures; staples; etc. - see MRI safety questionnaire annex)
• Subject or their parent(s)/legal guardian(s) refuse to be informed of incidental findings detected during MRI
• Claustrophobia

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Central Study Contacts

KAVOUNOUDIAS

CONTACT

+33(0)4 13 55 08 42; anne.kavounoudias@univ-amu.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Propsective, monocentric, comparative study

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)