Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis

Last updated: January 19, 2024
Sponsor: St. Justine's Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Long-term bracing: Conventional Brace

Immediate in-brace correction: Conventional Brace

Immediate in-brace correction: Optimized Brace

Clinical Study ID

NCT05001568
20223437
  • Ages 10-16
  • All Genders

Study Summary

Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • AIS diagnosis
  • Risser 0-2
  • Primary curve angles 20 degrees - 40 degrees
  • If female, either premenarchal or less than 18 months postmenarchal.

Exclusion

Exclusion Criteria:

  • Patients with a pre-existing cardiovascular condition
  • Patients with a symptom of a neurological disorder
  • Patients with any other disorder of the musculoskeletal system affecting the lowerlimbs
  • Pregnancy

Study Design

Total Participants: 58
Treatment Group(s): 4
Primary Treatment: Long-term bracing: Conventional Brace
Phase:
Study Start date:
November 15, 2021
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • CHU Sainte-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

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