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

NCT03978273 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-03-18

No results posted yet for this study

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.

Conditions

  • Idiopathic Scoliosis

Interventions

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.

Sponsors & Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

    collaborator NETWORK

  • University Grenoble Alps

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Aurelien COURVOISIER, MD, PhD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978273 on ClinicalTrials.gov