Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients (COVIRSCOL)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Idiopathic Scoliosis

Treatments: Other: Night-time brace only; Device: Night-time brace + virtual-brace

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03978273

38RC18.053

Details and patient eligibility

About

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.

Full 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).

Enrollment: 74 estimated patients

Sex: All

Ages: 9 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Night-time brace + virtual-brace

Experimental group

Description:

Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).

Treatment:

Device: Night-time brace + virtual-brace

Night-time brace only

Active Comparator group

Description:

Patients are conventionally treated with night-time brace only.

Treatment:

Other: Night-time brace only