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

Status unconfirmed · Not applicable

Conditions studied: Scoliosis

In brief

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.

Key facts

Study ID

NCT00256672

Run by

Shriners Hospitals for Children

People needed

88

Starts

2005-06-01

Expected to finish

2012-12-01

Last updated by the study team

2008-06-13

Who can join

Age: 5 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children with C5 to L2 SCI.
• ASIA impairment levels A, B, or C.
• Age greater than 5 up to one year before end of growth (14 in girls, 16 in boys)
• A single structural curve <40 degrees or a double curve <40 degrees where the largest compensatory curve is <25 degrees on bending film.
• Children at risk for Paralytic Scoliosis
• Ability to follow simple instructions.

You may not qualify if…

• Curve magnitude >40 degrees, pressure sores over the trunk.
• Inability to tolerate TLSO wears.
• Structural compensatory curves of 25 degrees or greater (double structural curves).
• Severe Traumatic Brain Injury, TBI (8 and below on Glasgow Coma Scale).
• Cognitive Impairment
• Less than 6 months from date of injury

Where it is running

• 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

Full record on ClinicalTrials.gov

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