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

Primary Purpose

Idiopathic Scoliosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Night-time brace + virtual-brace
Night-time brace only
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Scoliosis focused on measuring Vertebral column, Rehabilitation, Virtual-brace, Posture

Eligibility Criteria

9 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University Hospital GrenobleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Night-time brace + virtual-brace

Night-time brace only

Arm Description

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

Patients are conventionally treated with night-time brace only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)
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.
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.
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.
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.

Full Information

First Posted
May 15, 2019
Last Updated
March 17, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network, University Grenoble Alps
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1. Study Identification

Unique Protocol Identification Number
NCT03978273
Brief Title
Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network, University Grenoble Alps

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
Keywords
Vertebral column, Rehabilitation, Virtual-brace, Posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Night-time brace + virtual-brace
Arm Type
Experimental
Arm Description
Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
Arm Title
Night-time brace only
Arm Type
Active Comparator
Arm Description
Patients are conventionally treated with night-time brace only.
Intervention Type
Device
Intervention Name(s)
Night-time brace + virtual-brace
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Night-time brace only
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1).
Description
Conventional 3D motion capture analysis with surface ElectroMyoGram (EMG) pattern's at D0, D90 and D180.
Time Frame
6 months
Title
Quantification of the quality of life evaluated with the Scoliosis Research Society Patient questionnaire (SRS-22), for both groups G0 and G1.
Description
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.
Time Frame
6 months
Title
Quantification of kinematic feedback provided by the virtual-brace and their deviation from the prescription (only for group G1)
Description
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)
Time Frame
6 months
Title
Treatment compliance for the rigid-brace (for both group G1 and G0)
Description
Compliance with the wearing of the rigid brace reported in the patient follow-up logbook.
Time Frame
6 months
Title
Treatment compliance for the virtual-brace (only for group G1)
Description
Only for group G1 : effective rehabilitation time collected from the virtual brace's log files.
Time Frame
6 months
Title
Quantification of electroencephalogram (EEG) modifications during postural and walk initiation tasks (for both groups G0 and G1).
Description
Conventional 3D motion capture analysis with EEG records at D0, D90 and D180.
Time Frame
6 months
Title
Exploratory Objective : Descriptive analysis by group of all parameters related to postural disorders recorded during Conventional 3D motion capture analysis with EMG, EEG.
Description
Set of variables related to the severity of the postural disorder.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelien COURVOISIER, MD, PhD
Phone
476767313
Ext
0033
Email
Echipon@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie CHIPON, PhD
Phone
476767313
Ext
0033
Email
Echipon@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelien COURVOISIER, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelien COURVOISIER, MD, PhD
Email
Echipon@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jacques GRIFFET, MD, PhD
First Name & Middle Initial & Last Name & Degree
Veronique BOURG-ROSTAING, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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