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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI

    Radiation

    Brain and Spinal Cord MRI

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Patients with Adolescent Idiopathic ScoliosisExperimental treatment 1 intervention
Group B: Healthy subjectsNo intervention 0 interventions

Trial outcomes

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

Time frame
One day before surgery

Secondary outcomes

1

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

We are expecting lower resting-state functional connectivity in patients' sensorimotor network compared to control subjects. We will estimate significant differences in functional connectivity between the 2 groups by comparing connectivity maps

Time frame
One day before surgery
2

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 (°)

Identification of the sensorimotor network regions that are most strongly connected in relation to proprioceptive performance by including the illusory range-of-motion index as a co-variate

Time frame
Day before surgery
3

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 (°)

Dynamic proprioceptive sensitivity - reflected by range-of-motion index - and proprioceptive static sensitivity - reflected by repositioning error - in relation to scoliosis severity estimated on the basis of patients' Cobb angle.

Time frame
One day before surgery
4

Analysis of scores on body perception as assed by the BESAA

Assessment of body perception by the Body-Esteem Scale for Adolescents and Adults, zero is equivalent to low body perception and 4 is good body perception for each item.

Time frame
From day one after surgery to 14 day after surgery

Other outcomes

Sponsors and contacts

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