Status:
UNKNOWN
Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury
Lead Sponsor:
Shriners Hospitals for Children
Conditions:
Scoliosis
Eligibility:
All Genders
5-16 years
Phase:
NA
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 o...
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 I...
Eligibility Criteria
Inclusion
- Children with C5 to L2 SCI.
- ASIA impairment levels A, B, or C.
- Age greater than 5 up to one year before end of growth (14 in girls, 16 in boys)
- A single structural curve \<40 degrees or a double curve \<40 degrees where the largest compensatory curve is \<25 degrees on bending film.
- Children at risk for Paralytic Scoliosis
- Ability to follow simple instructions.
Exclusion
- Curve magnitude \>40 degrees, pressure sores over the trunk.
- Inability to tolerate TLSO wears.
- Structural compensatory curves of 25 degrees or greater (double structural curves).
- Severe Traumatic Brain Injury, TBI (8 and below on Glasgow Coma Scale).
- Cognitive Impairment
- Less than 6 months from date of injury
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00256672
Start Date
June 1 2005
End Date
December 1 2012
Last Update
June 13 2008
Active Locations (3)
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1
Shriners Hospital for Children - Northern California
Sacramento, California, United States, 95817
2
Shriners Hospital for Children - Chicago
Chicago, Illinois, United States, 60707
3
Shriners Hospital for Children - Philadelphia
Philadelphia, Pennsylvania, United States, 19140