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

Shriners Hospitals for Children88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Scoliosis

Interventions

Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-FoamDEVICE

TLSO back brace, Flex-Foam (Posterior Opening)

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (3)

Shriners Hospital for Children - Northern California

Sacramento, California, United States

Shriners Hospital for Children - Chicago

Chicago, Illinois, United States

Shriners Hospital for Children - Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.