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Orthopedic Brace

Green Sun Dynamic Brace for Adolescent Idiopathic Scoliosis (GSM Trial)

N/A
Waitlist Available
Led By Luke Stikeleather, BSW, CO
Research Sponsored by National Scoliosis Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 18 months
Awards & highlights

GSM Trial Summary

This study is evaluating whether a brace which is designed to improve posture may help adolescents with scoliosis.

Eligible Conditions
  • Adolescent Idiopathic Scoliosis

GSM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months 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 Out-of-brace Cobb angle
Difference between in-brace curve correction
Unanticipated adverse events
Secondary outcome measures
Change in Brace-related quality of life scores (Brace Questionnaire)
Difference in Chest wall range of motion measured by vital capacity

GSM Trial Design

1Treatment groups
Experimental Treatment
Group I: Green Sun Dynamic BraceExperimental Treatment1 Intervention
Historical measures of brace effectiveness (in- and out-of-brace Cobb angles), wear time, and brace-related quality of life will be compared to those measured after the subject is fit with a Green Sun dynamic brace.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Green Sun Dynamic Brace
2018
N/A
~20

Find a Location

Who is running the clinical trial?

National Scoliosis CenterLead Sponsor
Children's Mercy Kansas CityUNKNOWN
Children's Hospital Los AngelesOTHER
232 Previous Clinical Trials
5,076,720 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Texas
How old are they?
< 18
What site did they apply to?
Children's Hospital of Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Green Sun Medical Dynamic Scoliosis Brace
Lori A Dolan 2018. "Green Sun Medical Dynamic Scoliosis Brace". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03641469.
~3 spots leftby Apr 2025
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