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

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ClinicalTrials.gov Identifier: NCT03978273
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Clinical Investigation Centre for Innovative Technology
University Grenoble Alps
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date June 7, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
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. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Quantification of kinematic, postural and electromyographic anomalies during trunk tilting and rotation (for both groups G0 and G1). [ Time Frame: 6 months ]
    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. [ Time Frame: 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 feedback provided by the virtual-brace and their deviation from the prescription (only for group G1) [ Time Frame: 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) [ Time Frame: 6 months ]
    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) [ Time Frame: 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). [ Time Frame: 6 months ]
    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. [ Time Frame: 6 months ]
    Set of variables related to the severity of the postural disorder.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Scoliosis
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Experimental: Night-time brace + virtual-brace
    Patients are conventionally treated with night-time brace. Additionally, they use the new developped virtual-brace (MD).
    Intervention: Device: Night-time brace + virtual-brace
  • Active Comparator: Night-time brace only
    Patients are conventionally treated with night-time brace only.
    Intervention: Other: Night-time brace only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aurelien COURVOISIER, MD, PhD 476767313 ext 0033 Echipon@chu-grenoble.fr
Contact: Emilie CHIPON, PhD 476767313 ext 0033 Echipon@chu-grenoble.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978273
Other Study ID Numbers  ICMJE 38RC18.053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE
  • Clinical Investigation Centre for Innovative Technology
  • University Grenoble Alps
Investigators  ICMJE
Principal Investigator: Aurelien COURVOISIER, MD, PhD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP