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Orthoses

2 for Scoliosis

N/A
Waitlist Available
Led By Randal R Betz, MD
Research Sponsored by Shriners Hospitals for Children
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 5 years
Awards & highlights

Study Summary

The purpose of this study is to determine whether full-time high dose prophylactic bracing (23 hours or more per day) is more effective than low dose bracing (12 hours or less per day) in preventing or delaying spinal curve progression in children with scoliosis after spinal cord injury.

Eligible Conditions
  • Scoliosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Global Measures (at the time of consent and every 6 months for 5 years): Four different questionnaires to monitor function, satisfaction, and quality of life.
Reachable Workspace Assessment (at the time of consent and once a year for 5 years): performing functional tasks including reaching for the floor, overhead, and every 20-degree radius in between.
Timed Motor Assessment (at the time of consent and once a year for 5 years) to measure functional ability in daily life activities including putting on sweat pants, T-Shirt, transferring from wheelchair to bed, etc.
+1 more

Trial Design

2Treatment groups
Active Control
Group I: 2Active Control1 Intervention
Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)
Group II: 1Active Control1 Intervention
High-dose Thoraco-Lumbar-Sacral Orthoses wear (>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)

Find a Location

Who is running the clinical trial?

Shriners Hospitals for ChildrenLead Sponsor
97 Previous Clinical Trials
23,876 Total Patients Enrolled
8 Trials studying Scoliosis
1,460 Patients Enrolled for Scoliosis
Randal R Betz, MDPrincipal InvestigatorShriners Hospital for Children, Philadelphia
Lawrence Vogel, MDPrincipal InvestigatorShriners Hospital for Children, Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Pediatric OrthopaedicsJournal
The POSNA Pediatric Musculoskeletal Functional Health Questionnaire: Report on Reliability, Validity, and Sensitivity to Change
Daltroy, Lawren H., Matthew H. Liang, Anne H. Fossel, and Michael J. Goldberg. 1998. “The POSNA Pediatric Musculoskeletal Functional Health Questionnaire: Report on Reliability, Validity, and Sensitivity to Change”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00004694-199809000-00001.
Canadian Journal of Occupational TherapyJournal
Pilot Testing of the Canadian Occupational Performance Measure: Clinical and Measurement Issues
Law, Mary, Helene Polatajko, Nancy Pollock, Mary Ann Mccoll, Anne Carswell, and Sue Baptiste. 1994. “Pilot Testing of the Canadian Occupational Performance Measure: Clinical and Measurement Issues”. Canadian Journal of Occupational Therapy. SAGE Publications. doi:10.1177/000841749406100403.
Medical CareJournal
The Pedsql™: Measurement Model for the Pediatric Quality of Life Inventory
Varni, James W., Michael Seid, and Cheryl A. Rode. 1999. “The Pedsql™: Measurement Model for the Pediatric Quality of Life Inventory”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005650-199902000-00003.
Canadian Journal of Occupational TherapyJournal
The canadian occupational performance measure: an outcome measure for occupational therapy
Law, Mary, Sue Baptiste, MaryAnn McColl, Anne Opzoomer, Helene Polatajko, and Nancy Pollock. 1990. “The canadian occupational performance measure: an outcome measure for occupational therapy”. Canadian journal of occupational therapy. SAGE Publications. doi:10.1177/000841749005700207.
All > Scoliosis
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