This trial is active, not recruiting.

Condition scoliosis
Treatment thoraco-lumbar-sacral-orthoses (tlso) / flex-foam
Sponsor Shriners Hospitals for Children
Start date June 2005
End date December 2009
Trial size 88 participants
Trial identifier NCT00256672, 9155-200513332


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
High-dose Thoraco-Lumbar-Sacral Orthoses wear (>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)
thoraco-lumbar-sacral-orthoses (tlso) / flex-foam
TLSO back brace, Flex-Foam (Posterior Opening)
(Active Comparator)
Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)
thoraco-lumbar-sacral-orthoses (tlso) / flex-foam
TLSO back brace, Flex-Foam (Posterior Opening)

Primary Outcomes

X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis.
time frame: 5 years
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
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
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

Eligibility Criteria

Male or female participants from 5 years up to 16 years old.

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

Additional Information

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
Principal investigator Craig M McDonald, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Shriners Hospitals for Children.