Optimized Nighttime Brace for Scoliosis

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: St. Justine's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for young people with Adolescent Idiopathic Scoliosis (AIS) who have a primary curve of their spine between 20-40 degrees. Girls should be early in puberty, and all participants must not have advanced bone maturity (Risser 0-2). It's not open to those with cardiovascular or neurological disorders, other musculoskeletal issues affecting the legs, or if pregnant.

Inclusion Criteria

I am a female who has not started menstruating or started less than 18 months ago.

I have been diagnosed with AIS.

My skeletal maturity is at a Risser stage of 0 to 2.

+1 more

Exclusion Criteria

I am experiencing symptoms of a neurological disorder.

I have a condition affecting my legs.

I have a heart condition.

+1 more

Participant Groups

The study tests two types of braces for scoliosis: a conventional brace and an optimized brace designed using a new method tailored to each patient. The effectiveness of immediate correction by both braces and their long-term use will be compared.

2Treatment groups

Experimental Treatment

Active Control

Group I: Optimized Providence braceExperimental Treatment3 Interventions

The braces will be designed using optimization and finite element analysis.

Group II: Conventional Providence braceActive Control3 Interventions

The braces will be designed by an orthotist using the conventional design method.