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| Sponsored by: |
Shriners Hospitals for Children |
| Information provided by: | Shriners Hospitals for Children |
| ClinicalTrials.gov Identifier: | NCT00256672 |
Purpose
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.
| Condition | Intervention |
|
Scoliosis |
Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam |
| Genetics Home Reference related topics: | Scoliosis |
| MedlinePlus related topics: | Scoliosis Spinal Cord Injuries |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Effectiveness of Full-Time Prophylactic Bracing at Preventing or Delaying Curve Progression in Paralytic Scoliosis Secondary to Spinal Cord Injury in the Growing Child: Randomized Trial |
| Estimated Enrollment: | 88 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
High-dose Thoraco-Lumbar-Sacral Orthoses wear (>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)
|
Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
TLSO back brace, Flex-Foam (Posterior Opening)
|
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2: Active Comparator
Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)
|
Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
TLSO back brace, Flex-Foam (Posterior Opening)
|
This is a randomized control trial to determine the effectiveness of high dose bracing (≥ 23 hours per day) and low dose bracing (≤ 12 hours per day) in skeletally immature children with Spinal Cord Injury. Subjects will be randomized into either a prophylactic high dose-bracing group (≥ 23 hours per day) or low dose-bracing group (≤ 12 hours per day). Subjects will be stratified by age (younger than age 10 and older than age 10), and curve severity (< 20 degrees and 20-40 degrees) using a matching random blocks design.
Eligibility
| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| Shriners Hospital for Children - Northern California | |||||
| Sacramento, California, United States, 95817 | |||||
| United States, Illinois | |||||
| Shriners Hospital for Children - Chicago | |||||
| Chicago, Illinois, United States, 60707 | |||||
| United States, Pennsylvania | |||||
| Shriners Hospital for Children - Philadelphia | |||||
| Philadelphia, Pennsylvania, United States, 19140 | |||||
| Shriners Hospitals for Children |
| Principal Investigator: | Craig M McDonald, MD | Shriners Hospital for Children, Northern California |
| Principal Investigator: | Randal R Betz, MD | Shriners Hospital for Children, Philadelphia |
| Principal Investigator: | Lawrence Vogel, MD | Shriners Hospital for Children, Chicago |
More Information
Official website for Shriners Hospitals for Children, a network of 22 hospitals that provide expert, no-cost orthopaedic and burn care to children under 18 
  |
| Responsible Party: | Shriners Hospital for Children ( Craig McDonald, MD, principal investigator ) |
| Study ID Numbers: | 9155-200513332 |
| First Received: | November 16, 2005 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00256672 |
| Health Authority: | United States: Institutional Review Board |
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