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Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

Study acronym: RCT-RPG
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 16, 2024 (before its estimated March 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Jul 1, 2024 to Mar 1, 2025v5 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 144 to confirmed 47
    • Study completion date: Apr 2025 to Sep 2026
    • Secondary endpoints: 6 to 4
    • Site details revised at 2 of 2 sites
  2. Notable Primary completion date: Nov 2022 to Jul 1, 2024v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2020 to Aug 15, 2021
    • Secondary endpoints: 7 to 6
    v3
  4. Notable Primary endpoint revised
    • Secondary endpoints revised (7)
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.
Trial Details
NCT Number NCT04568759
Lead Sponsor St. Justine's Hospital
Collaborators: Laval University, Shriners Hospitals for Children, Université de Montréal, CHU de Québec
Conditions
(from sponsor)
Adolescent Idiopathic Scoliosis
Related terms Back Pain, Respiratory Aspiration
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov