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

June 11, 2008 updated by: Shriners Hospitals for Children

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Shriners Hospital for Children - Northern California
    • Illinois
      • Chicago, Illinois, United States, 60707
        • Shriners Hospital for Children - Chicago
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Shriners Hospital for Children - Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
High-dose Thoraco-Lumbar-Sacral Orthoses wear (>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)
Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
TLSO back brace, Flex-Foam (Posterior Opening)
Active Comparator: 2
Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)
Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
TLSO back brace, Flex-Foam (Posterior Opening)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Craig M McDonald, MD, Shriners Hospital for Children, Northern California
  • Principal Investigator: Randal R Betz, MD, Shriners Hospital for Children, Philadelphia
  • Principal Investigator: Lawrence Vogel, MD, Shriners Hospital for Children, Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 16, 2005

First Submitted That Met QC Criteria

November 16, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 13, 2008

Last Update Submitted That Met QC Criteria

June 11, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9155-200513332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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