← Back to Search

Orthopedic Device

Optimized Nighttime Brace for Scoliosis

N/A

Waitlist Available

Research Sponsored by St. Justine's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If female, either premenarchal or less than 18 months postmenarchal.

AIS diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 2 years

Awards & highlights

Study Summary

This trial is testing a new method for designing braces to correct adolescent idiopathic scoliosis, which affects 3-4% of Canadians.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the trial does not list specific side effects, wearing braces can typically cause discomfort, skin irritation, and potential impact on self-image due to body changes. Long-term bracing might also affect muscle development.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I have been diagnosed with AIS.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year, 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year, 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cobb angle

Secondary outcome measures

Immediate in-brace Cobb angle

Quality of Life (QoL) - MOBI

Quality of Life (QoL) - SRS-22r

+1 more

Trial Design

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

78,971 Total Patients Enrolled

10 Trials studying Scoliosis

1,963 Patients Enrolled for Scoliosis

Media Library

Conventional Brace (Orthopedic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05001568 — N/A

Scoliosis Research Study Groups: Optimized Providence brace, Conventional Providence brace

Scoliosis Clinical Trial 2023: Conventional Brace Highlights & Side Effects. Trial Name: NCT05001568 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for adults aged eighteen and over to partake in this medical experiment?

"This particular clinical trial specifies that it is seeking individuals aged 10 to 16. Altogether, there are 69 trials for persons under the age of 18 and another 14 studies catering to those above retirement-age."

Answered by AI

Am I eligible to partake in this experiment?

"The research enrolment is open to 58 adolescents affected by scoliosis, ranging in ages from 10-16. Critical eligibility criteria must be met; female patients should either not have gone through menarche or had their last period within 18 months prior to the trial beginning. Furthermore, all participants need to have a Risser 0-2 score."

Answered by AI

Are there vacancies open for participants in this experiment?

"Clinicaltrials.gov confirms that this medical research is actively recruiting. The trial was initially posted on November 15th 2021, and the latest information about it was added to the system on May 4th 2022."

Answered by AI

What is the current participant count of this clinical trial?

"That is correct. Per the information on clinicaltrials.gov, this study commenced recruitment activities on November 15th 2021 and was most recently updated in May 4th 2022. The total number of participants needed is 58 from one single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Hubert Labelle, MD 2021. "Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05001568.

All > Scoliosis