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

Shriners Hospitals for Children

Status: Unknown

Conditions: Scoliosis

Treatments: Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

Study type: Interventional

Funder types: Other

Identifiers

NCT00256672

9155-200513332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

1

Active Comparator group

Description:

High-dose Thoraco-Lumbar-Sacral Orthoses wear (\>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)

Treatment:

Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

2

Active Comparator group

Description:

Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)

Treatment:

Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam