Clinical trial NCT03978273: Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients
Official title: Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients: A Prospective, Monocentric, Randomized With Stratification on the Type of Scoliosis, Comparative and Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: Vertebral column
Rehabilitation
Virtual-brace
Posture
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: University Grenoble Alps
First posted: 2019-06-07
Enrollment: 74
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls.

The treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. The place of rehabilitation is disputed because the methods are multiple, non-standardized and the sessions are infrequent.

In a previous study (MOUVSCO, NTC02134704), researchers have identified systematic postural abnormalities in patients with scoliosis, and developped a virtual-brace (medical device, MD) to allow real-time self-correction of the trunk position.

The aim of the present study is to evaluate for the first time the efficacy of the virtual-brace on the correction of the posture of scoliotic patients.

The hypothesis is that intensified rehabilitation with the virtual-brace will improve pathological postures related to scoliosis.

Detailed description: The present study is the first evaluation of the efficacy of the virtual-brace on scoliotic patients.

The efficacy of rehabilitation will be estimate on the correction of the posture of scoliosis patients over 6 months by comparing 2 groups: a control group of patients conventionally treated with a night-time brace (G0 group_conventional) and an experimental group of patients wearing a night-time brace, doing postural rehabilitation exercises with the virtual brace and follow-up visits with a physiotherapist (G1 group_virtual-brace).

Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic scoliosis (left lumbar or right thoracic),
* Patients with moderate scoliosis: Cobb angle assessed on the last radiography between 20 ° and 35 °,
* Patients requiring the wearing of a rigid night-time brace,
* Patients having a home computer,
* Patients affiliated to social security or similarly regime,
* Patients who gave their consent to participate in the study,
* Patients whose 2 parents have signed the informed consent

Exclusion Criteria:

* Patients with an unstabilized medical problem,
* Patients with known allergy to elastane,
* Patients with sensitivity to dizziness,
* Patients with pacemaker,
* Patients with implanted cardiac defibrillator,
* Patients with cochlear implant,
* Patients carrying a non-removable metal element,
* Protected patient concerned by articles L1121-5 and L1121-6 of the Public Health Code,
* Patients whose parents are protected by article L1121-8 of the Public Health Code

Primary outcomes:
measure: Medio-lateral displacement during lateral inclination of scoliosis patients in the group with rehabilitation enriched by the virtual brace (group G1) compared with the reference treatment (group G0) at D180.
timeFrame: 6 months
Secondary outcomes:
measure: Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).
timeFrame: 6 months
measure: Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.
timeFrame: 6 months
measure: Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)
timeFrame: 6 months
measure: Treatment compliance for the rigid-brace (for both group G1 and G0)
timeFrame: 6 months
measure: Treatment compliance for the virtual-brace (only for group G1)
timeFrame: 6 months
measure: Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).
timeFrame: 6 months
measure: Exploratory Objective : Descriptive analysis by group of all parameters related to postural disorders recorded during Conventional 3D motion capture analysis with EMG, EEG.
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Aurelien COURVOISIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: