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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shriners Hospitals for Children.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00256672
First received: November 16, 2005
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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 Intervention
Scoliosis
Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: June 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256672

Locations
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
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
  More Information

Additional Information:
Publications:
Betz RR & Mulcahey MJ. Spinal Cord Injury Rehabilitation, In: The Pediatric Spine: Principles and Practice, S.L. Weinstein (eds). New York: Raven press, 1994.
Campbell J, Bonnett C. Spinal cord injury in children. Clinical Orthopaedics 1975; 112:114-123.
Lou E, Raso VJ, Hill DL, Durdle NG, Mahood JK, Moreau M: Brace Monitoring System for the Treatment of Scoliosis. In Research into Spinal Deformities 4 (Ed A. Tanguy & B. Peuchot) Series Studies in Health Technology and Informatics. IOS Press Oxford, 88: pp. 218-221, 2002.
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.

Responsible Party: Craig McDonald, MD, principal investigator, Shriners Hospital for Children
ClinicalTrials.gov Identifier: NCT00256672     History of Changes
Other Study ID Numbers: 9155-200513332
Study First Received: November 16, 2005
Last Updated: June 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Spinal Cord Injury
TLSO brace
Spine curvature
Child
Effectiveness of bracing

Additional relevant MeSH terms:
Scoliosis
Spinal Cord Injuries
Wounds and Injuries
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 21, 2014