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

Idiopathic Scoliosis Clinical Trial

— COVIRSCOL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978273
• Other study ID #: 38RC18.053
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: April 2023

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: Aurelien COURVOISIER, MD, PhD
• Phone: 476767313
• Email: Echipon[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Night-time brace + virtual-brace
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months. Additionally : They will perform 5 sessions of postural rehabilitation exercises per week (each of 30 minutes) with the virtual-brace (MD). They will have also follow up consultations with a physiotherapist every 21 days, to evaluate treatment observance and to adapt postural exercises according to the results and difficulties encountered. Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.

Other:
• Night-time brace only
Patients will receive conventional treatment : wearing a night-time brace every night during 6 months. Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180.

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology, University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	6 months
Secondary	Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).	Conventional 3D motion capture analysis with surface ElectroMyoGram (EMG) pattern's at D0, D90 and D180.	6 months
Secondary	Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.	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.	6 months
Secondary	Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)	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)	6 months
Secondary	Treatment compliance for the rigid-brace (for both group G1 and G0)	Compliance with the wearing of the rigid brace reported in the patient follow-up logbook.	6 months
Secondary	Treatment compliance for the virtual-brace (only for group G1)	Only for group G1 : effective rehabilitation time collected from the virtual brace's log files.	6 months
Secondary	Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).	Conventional 3D motion capture analysis with EEG records at D0, D90 and D180.	6 months
Secondary	Exploratory Objective : Descriptive analysis by group of all parameters related to postural disorders recorded during Conventional 3D motion capture analysis with EMG, EEG.	Set of variables related to the severity of the postural disorder.	6 months