NCT00256672

Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Shriners Hospitals for Children · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis

Interventions

Type	Name	Description
DEVICE	Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam	TLSO back brace, Flex-Foam (Posterior Opening)

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-12-01
• Completion: 2012-12-01
• First posted: 2005-11-21
• Last updated: 2008-06-13

Locations

3 sites across 1 country: United States