Clinical trial NCT00256672: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis
Keywords: Spinal Cord Injury
TLSO brace
Spine curvature
Child
Effectiveness of bracing
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 88
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Shriners Hospital for Children - Northern California
state: California
city: Chicago
country: United States
facility: Shriners Hospital for Children - Chicago
state: Illinois
city: Philadelphia
country: United States
facility: Shriners Hospital for Children - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Shriners Hospital for Children, Northern California
name: Craig M McDonald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shriners Hospital for Children, Philadelphia
name: Randal R Betz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shriners Hospital for Children, Chicago
name: Lawrence Vogel, MD
role: PRINCIPAL_INVESTIGATOR
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