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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Idiopathic Scoliosis

Treatments

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

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)

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

Trial contacts and locations

1

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Central trial contact

Emilie CHIPON, PhD; Aurelien COURVOISIER, MD, PhD

Data sourced from clinicaltrials.gov

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