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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256672
Recruitment Status : Unknown
Verified June 2008 by Shriners Hospitals for Children.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2005
Last Update Posted : June 13, 2008
Information provided by:
Shriners Hospitals for Children

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.

Condition or disease Intervention/treatment Phase
Scoliosis Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2005
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis. [ Time Frame: 5 years ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00256672

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United States, California
Shriners Hospital for Children - Northern California
Sacramento, California, United States, 95817
United States, Illinois
Shriners Hospital for Children - Chicago
Chicago, Illinois, United States, 60707
United States, Pennsylvania
Shriners Hospital for Children - Philadelphia
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Shriners Hospitals for Children
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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

Additional Information:
Betz RR & Mulcahey MJ. Spinal Cord Injury Rehabilitation, In: The Pediatric Spine: Principles and Practice, S.L. Weinstein (eds). New York: Raven press, 1994.
Lou E, Durdle NG, Raso VJ, Hill DL: A Load Compliance Monitor System for the Treatment of Scoliosis. Proceedings of IEEE Canadian Conference on Electrical and Computer Engineering, Edmonton, Canada pp. 1501-1505, 1999.
Anderson C A, Vogel L C, Klaas SJ, Lubicky J P, Long-term outcomes and life satisfaction in pediatric spinal cord injury: a model for children with chronic disabilities. (Presented at the annual meeting of the American Academy of Cerebral Palsy and Developmental Medicine 1997). Dev. Med. Child Neurol. 1997; 39 (Suppl 75): 21.
Deutsch A, Braun S, Granger CV. The Functional Independence Measure and the Functional Independence Measure for Children: ten years of development. Crit Rev Med Rehab 1996; 8:267-281.

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Responsible Party: Craig McDonald, MD, principal investigator, Shriners Hospital for Children Identifier: NCT00256672    
Other Study ID Numbers: 9155-200513332
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: June 2008
Keywords provided by Shriners Hospitals for Children:
Spinal Cord Injury
TLSO brace
Spine curvature
Effectiveness of bracing
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases