Effectiveness of Full-time Prophylactic Bracing at Preventing or Delaying Curve Progression in Paralytic Scoliosis Secondary to SCI in the Growing Child: A Randomized Trial

Principal Investigator: Lawrence C. Vogel, M.D.
Co-Investigators: Caroline J. Anderson, Ph.D.; Adam Graf, M.S.; Gerald F. Harris, Ph.D.; Sahar Hassani, M.S.; Melissa M. Mendoza, PT, M.S., DPT

Purpose: To determine the effectiveness of full-time, high dose, prophylactic bracing versus twelve hours or less, low dose, bracing at preventing or delaying spinal curve progression secondary to spinal cord injury (SCI) in the growing child.

Significance: A thoracic-lumbar-sacral orthosis (TLSO) appears to either delay or prevent scoliosis in children with SCI if bracing is initiated with spinal curves less than 20 degrees. However, there have been no studies concerning the hours of bracing required to prevent or delay scoliosis. In addition, no studies have rigorously evaluated the efficacy of low dose-bracing versus high dose-bracing for the prevention or delay of scoliosis.

Methods: To obtain data on 88 subjects among the three Shriners Hospitals with SCI programs (Northern California, Philadelphia, and Chicago), the Chicago site is recruiting 29 subjects. Subjects from 5 to 16 years of age with a level of injury from C5 and L3 will be included. The scoliosis curve must consist of a single structural curve <40 degrees or a double curve <40 degrees where the largest compensatory curve is <25 degrees. A table of random numbers (1 to 100) will be used to assign subjects to either the high dose-bracing group or the low dose-bracing group. Subjects randomized to the high dose-bracing group will be instructed to wear the brace 23 hours per day. Subjects randomized to the low dose-bracing group will be instructed to wear the brace 12 hours per day. A temperature monitor will be attached to the TLSO and record whether the TLSO brace is on or off once every 15 minutes. The child and parents perception of their physical, emotional, and social wellbeing will be assessed by administering the following questionnaires: Paralytic Spine Deformity Outcomes Questionnaire (PSDOQ), the SRS – 22r, PedsQL, and the PODCI. They will be completed in the hospital or at home once every six months. To measure the subject’s functional ability in their daily activities a Timed Motor Performance Test and a reachable workspace assessment will be performed with the TLSO brace on and off once a year.