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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00256672

Enrollment

Registered

2005-11-21

Start date

2005-06-30

Completion date

2012-12-31

Last updated

2008-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Spinal Cord Injury, TLSO brace, Spine curvature, Child, Effectiveness of bracing

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.

Interventions

DEVICEThoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

TLSO back brace, Flex-Foam (Posterior Opening)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026