Optimized Nighttime Brace for Scoliosis

Overseen By Soraya Barchi

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Cardiovascular, Neurological, Musculoskeletal, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of brace for treating adolescent idiopathic scoliosis, a condition where the spine curves sideways during growth spurts. Researchers aim to determine if a custom-designed brace, optimized for better fit and correction, is more effective than a standard brace. Teens with a diagnosed curve between 20 and 40 degrees who are still growing might be suitable participants. The study seeks to improve brace design to help those with scoliosis live more comfortably. As an unphased trial, it offers a unique opportunity to contribute to advancements in scoliosis treatment and potentially benefit from a more comfortable brace design.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this optimized brace is safe for adolescents with scoliosis?

Research shows that nighttime braces, such as the Optimized Providence brace, are generally safe for treating scoliosis. Studies have found that these braces are usually comfortable to wear at night, and most kids and teens adapt to them without major issues.

The Optimized Providence brace is specially designed for a custom fit. Although recent studies don't provide detailed safety data, the custom fit often reduces discomfort and skin irritation, common concerns with braces.

Overall, scoliosis braces, including optimized ones, are widely used and have a good safety record. For any concerns or questions about side effects, it's best to consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Optimized Providence brace for scoliosis because it uses cutting-edge optimization and finite element analysis to enhance its design. Unlike the conventional Providence brace, which relies on traditional design methods by an orthotist, the optimized version aims to offer a more customized and potentially more effective fit for patients. This advanced approach could lead to improved comfort and better spinal correction during nighttime use, making it a promising development for scoliosis management.

What evidence suggests that this trial's braces could be effective for scoliosis?

Research shows that the Providence nighttime brace is as effective as a full-time brace for treating moderate curves in adolescent idiopathic scoliosis (AIS). Studies have found that this brace works well for patients with certain spine curves, especially those below the T6 vertebra. In this trial, participants will join one of two groups: one will receive the Conventional Providence brace, while the other will receive the Optimized Providence brace. The new brace being tested uses advanced design techniques to improve results by tailoring the fit and pressure points for each patient. This aims to provide better and more comfortable correction during nighttime use. Existing evidence supports the effectiveness of the Providence brace, and the new version is expected to offer even greater benefits. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am experiencing symptoms of a neurological disorder.

I have a condition affecting my legs.

I have a heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a customized Providence brace designed using optimization and finite element analysis

2 years

Regular visits for brace fitting and adjustments

Follow-up

Participants are monitored for changes in Cobb angle and quality of life

2 years

Annual visits for radiographic analysis and QoL assessments

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Brace
• Optimized Brace

Trial Overview 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.

How Is the Trial Designed?

Group I: Optimized Providence brace Experimental Treatment 3 Interventions

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

Group II: Conventional Providence brace Active Control 3 Interventions

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

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666548422000816

Providence nighttime brace is as effective as fulltime ... Both brace regimes are equally effective in treating moderate AIS curves with apex of the main curve below T6 in immature female patients older than 10 years.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05001568

Validation of a New Optimized Nighttime Providence Brace ... In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application. Official Title.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0292069

Optimized braces for the treatment of adolescent idiopathic ... The objective of this randomized controlled trial is to compare and validate such FEM semi-automatic algorithm used to design nighttime Providence-type braces.

4. mdpi.com mdpi.com/2077-0383/12/24/7684

Nighttime versus Fulltime Brace Treatment for Adolescent ... The purpose of this study is to retrospectively compare the effectiveness of fulltime Boston Brace (BB) and Providence Nighttime Brace (PNB) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3233933/

Effectiveness of the Providence nighttime bracing in ... The aim of this study was to assess the effectiveness of the Providence brace in idiopathic scoliosis with low apexes and compare the results with matched ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8603182/

Brace treatment for patients with scoliosis: State of the art The purpose of this article is to provide recommendations with respect to the most appropriate bracing approach in general.

7. nature.com nature.com/articles/s41598-024-53586-z

Automated design of nighttime braces for adolescent ... We propose a new automated design method for creating bespoke nighttime braces requiring virtually no user input in the process.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814328

Nighttime Bracing or Exercise in Moderate-Grade ... Results of this study suggest that nighttime bracing is an effective alternative intervention in patients rejecting full-time bracing.