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

This study is ongoing, but not recruiting participants.
Study NCT00256672.   Last updated on June 11, 2008.   Information provided by Shriners Hospitals for Children

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury
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
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 Phase
Study Type † Interventional
Study Design † Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Primary Outcome Measure † X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measure †
Condition † Scoliosis
Intervention † Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
MEDLINE PMIDs 11869904,   15218932,   12626930,   2772729,   2312704,   12043927,   7451526,   3350947,   6562445,   11805670,   10412999,   7302685,   7320032,   10786513,   15503701,   10489007,   10404571,   9746401,   10104738,   10137673,   10024117
Links 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 This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Active, not recruiting
Enrollment † 88
Start Date † June 2005
Completion Date December 2012
Eligibility Criteria †

Inclusion Criteria:

  1. Children with C5 to L2 SCI.
  2. ASIA impairment levels A, B, or C.
  3. Age greater than 5 up to one year before end of growth (14 in girls, 16 in boys)
  4. A single structural curve <40 degrees or a double curve <40 degrees where the largest compensatory curve is <25 degrees on bending film.
  5. Children at risk for Paralytic Scoliosis
  6. Ability to follow simple instructions.

Exclusion Criteria:

  1. Curve magnitude >40 degrees, pressure sores over the trunk.
  2. Inability to tolerate TLSO wears.
  3. Structural compensatory curves of 25 degrees or greater (double structural curves).
  4. Severe Traumatic Brain Injury, TBI (8 and below on Glasgow Coma Scale).
  5. Cognitive Impairment
  6. Less than 6 months from date of injury
Gender Both
Ages 5 Years to 16 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00256672
Organization ID 9155-200513332
Secondary IDs ††
Study Sponsor † Shriners Hospitals for Children
Collaborators ††
Investigators †
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    
Information Provided By Shriners Hospitals for Children
Verification Date June 2008
First Received Date † November 16, 2005
Last Updated Date June 11, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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