NCT03978273

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 9 Years – 16 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Idiopathic Scoliosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-11
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2019-06-07
• Last updated: 2020-03-18

Locations

1 site across 1 country: France