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

Not Applicable

• Conditions: Idiopathic Scoliosis
• Interventions: Device: Night-time brace + virtual-brace; Other: Night-time brace only

• Registration Number: NCT03978273
• Lead Sponsor: University Hospital, Grenoble

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).

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-07
• Study Start: 2019-10-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Night-time brace + virtual-brace	Night-time brace + virtual-brace	Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
Night-time brace only	Night-time brace only	Patients are conventionally treated with night-time brace only.

Primary Outcome Measures

Name	Time	Method
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.	6 months	Difference between D180 and D0 of the medio-lateral displacement of the pressure center during the lateral inclination in both groups G0 and G1. This parameter is evaluated during the conventional 3D motion capture analysis.

Secondary Outcome Measures

Name	Time	Method
Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)	6 months	Time course of the angular data of the trunk relative to the pelvis provided by the virtual brace, versus the prescribed exercises (evaluated every 3 weeks during the visit to the physiotherapist)
Treatment compliance for the rigid-brace (for both group G1 and G0)	6 months	Compliance with the wearing of the rigid brace reported in the patient follow-up logbook.
Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.	6 months	Difference in the result of the SRS-22 questionnaire between D180 and D0. SRS-22 is a self-reported questionnaire assessing self-image, function, pain, mental health, and satisfaction with care with score range from 1 to 5 (1=worst and 5= best) for each 22 questions. The global score is the mean score of all questions.
Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).	6 months	Conventional 3D motion capture analysis with surface ElectroMyoGram (EMG) pattern's at D0, D90 and D180.
Exploratory Objective : Descriptive analysis by group of all parameters related to postural disorders recorded during Conventional 3D motion capture analysis with EMG, EEG.	6 months	Set of variables related to the severity of the postural disorder.
Treatment compliance for the virtual-brace (only for group G1)	6 months	Only for group G1 : effective rehabilitation time collected from the virtual brace's log files.
Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).	6 months	Conventional 3D motion capture analysis with EEG records at D0, D90 and D180.

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France