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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00256672
First received: November 16, 2005
Last updated: June 11, 2008
Last verified: June 2008
History of Changes

November 16, 2005
June 11, 2008
June 2005
December 2009   (final data collection date for 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 ]
  • X-rays taken at the time of consent and every 6 months for 5 years to determine degree of scoliosis.
  • Timed Motor Assessment (at the time of consent and once a year for 5 years): putting on sweat pants and T-Shirt, transferring from wheelchair to bed, etc.)
  • Reachable Workspace Assessment (at the time of consent and once a year for 5 years): reaching to the floor, overhead, and different heights in between.
Complete list of historical versions of study NCT00256672 on ClinicalTrials.gov Archive Site
 
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.
 
 
 
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

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.

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.
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Scoliosis
Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
TLSO back brace, Flex-Foam (Posterior Opening)
  • Active Comparator: 1
    High-dose Thoraco-Lumbar-Sacral Orthoses wear (>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)
    Intervention: Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
  • Active Comparator: 2
    Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)
    Intervention: Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
88
December 2012
December 2009   (final data collection date for primary outcome measure)

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
Both
5 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00256672
9155-200513332
 
Craig McDonald, MD, principal investigator, Shriners Hospital for Children
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
Shriners Hospitals for Children
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP