Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256672
Status:
UNKNOWN
Last Update Posted:
2008-06-13
First Post:
2005-11-16
Brief Title:
Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None