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

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

This study is currently recruiting patients.
Verified by Shriners Hospitals for Children April 2007

Sponsored by: Shriners Hospitals for Children
Information provided by: Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00256672

clinical trials 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: TLSO brace

MedlinePlus related topics:  Scoliosis

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

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

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.
  • 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.
  • 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.
  • 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.

Total Enrollment:  88

Study start: June 2005;  Expected completion: December 2012

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.

clinical trials Eligibility

Ages Eligible for Study:  5 Years   -   16 Years,  Genders Eligible for Study:  Both
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

clinical trials Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00256672

Irmi M Feldman      916-453-2291    ifeldman@shrinenet.org
Mitell Sison      916-453-2282    msison@shrinenet.org

United States, California
      Shriners Hospital for Children - Northern California, Sacramento,  California,  95817,  United States; Recruiting
Irmi M Feldman  916-453-2291    ifeldman@shrinenet.org 
Mitell Sison  916-453-2282    msison@shrinenet.org 
Craig M McDonald, MD,  Principal Investigator
Anita Bagley, PhD,  Sub-Investigator

United States, Illinois
      Shriners Hospital for Children - Chicago, Chicago,  Illinois,  60707,  United States; Recruiting
Melissa Mendoza  773-385-5867    mmmendoza@shrinenet.org 
Carolyn Anderson, PhD   canderson@shrinenet.org 
Lawrence Vogel, MD,  Principal Investigator

United States, Pennsylvania
      Shriners Hospital for Children - Philadelphia, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
Lou Hunter  215-430-4205    lhunter@shrinenet.org 
Ross Chafetz  215-430-4114    rchafetz@shrinenet.org 
Randal R Betz, MD,  Principal Investigator

Study chairs or principal investigators

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

clinical trials More Information

Official website for Shriners Hospitals for Children, a network of 22 hospitals that provide expert, no-cost orthopaedic and burn care to children under 18

Publications

Rab G, Petuskey K, Bagley A. A method for determination of upper extremity kinematics. Gait Posture. 2002 Apr;15(2):113-9.

Kukke SN, Triolo RJ. The effects of trunk stimulation on bimanual seated workspace. IEEE Trans Neural Syst Rehabil Eng. 2004 Jun;12(2):177-85.

Palmieri TL, Petuskey K, Bagley A, Takashiba S, Greenhalgh DG, Rab GT. Alterations in functional movement after axillary burn scar contracture: a motion analysis study. J Burn Care Rehabil. 2003 Mar-Apr;24(2):104-8.

Betz RR & Mulcahey MJ. Spinal Cord Injury Rehabilitation, In: The Pediatric Spine: Principles and Practice, S.L. Weinstein (eds). New York: Raven press, 1994.

Brown JC, Zeller JL, Swank SM, Furumasu J, Warath SL. Surgical and functional results of spine fusion in spinal muscular atrophy. Spine. 1989 Jul;14(7):763-70.

Campbell J, Bonnett C. Spinal cord injury in children. Clinical Orthopaedics 1975; 112:114-123.

Dearolf WW 3rd, Betz RR, Vogel LC, Levin J, Clancy M, Steel HH. Scoliosis in pediatric spinal cord-injured patients. J Pediatr Orthop. 1990 Mar-Apr;10(2):214-8.

Lou E, Raso JV, Hill DL, Durdle NG, Mahood JK, Moreau MJ. The daily force pattern of spinal orthoses in subjects with adolescent idiopathic scoliosis. Prosthet Orthot Int. 2002 Apr;26(1):58-63.

Lancourt JE, Dickson JH, Carter RE. Paralytic spinal deformity following traumatic spinal-cord injury in children and adolescents. J Bone Joint Surg Am. 1981 Jan;63(1):47-53.

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.

DiRaimondo CV, Green NE. Brace-wear compliance in patients with adolescent idiopathic scoliosis. J Pediatr Orthop. 1988 Mar-Apr;8(2):143-6.

Gurnham RB. Adolescent compliance with spinal brace wear. Orthop Nurs. 1983 Nov-Dec;2(6):13-7. No abstract available.

Havey R, Gavin T, Patwardhan A, Pawelczak S, Ibrahim K, Andersson GB, Lavender S. A reliable and accurate method for measuring orthosis wearing time. Spine. 2002 Jan 15;27(2):211-4.

Lindeman M, Behm K. Cognitive strategies and self-esteem as predictors of brace-wear noncompliance in patients with idiopathic scoliosis and kyphosis. J Pediatr Orthop. 1999 Jul-Aug;19(4):493-9.

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.

Mayfield JK. Severe spine deformity in myelodysplasia and sacral agenesis: an aggressive surgical approach. Spine. 1981 Sep-Oct;6(5):498-509.

Mayfield JK, Erkkila JC, Winter RB. Spine deformity subsequent to acquired childhood spinal cord injury. J Bone Joint Surg Am. 1981 Dec;63(9):1401-11.

Vandal S, Rivard CH, Bradet R. Measuring the compliance behavior of adolescents wearing orthopedic braces. Issues Compr Pediatr Nurs. 1999 Apr-Sep;22(2-3):59-73.

Chafetz R, McDonald C, Mulcahey MJ, Betz R, Anderson C, Vogel L, Gaughan JP, Martin S, O'Dell MA, Flanagan A. Timed motor test for wheelchair users: initial development and application in children with spinal cord injury. J Spinal Cord Med. 2004;27 Suppl 1:S38-43.

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.

Bonaroti D, Akers JM, Smith BT, Mulcahey MJ, Betz RR. Comparison of functional electrical stimulation to long leg braces for upright mobility for children with complete thoracic level spinal injuries. Arch Phys Med Rehabil. 1999 Sep;80(9):1047-53.

Bridwell KH, Baldus C, Iffrig TM, Lenke LG, Blanke K. Process measures and patient/parent evaluation of surgical management of spinal deformities in patients with progressive flaccid neuromuscular scoliosis (Duchenne's muscular dystrophy and spinal muscular atrophy). Spine. 1999 Jul 1;24(13):1300-9.

Brown JC, Zeller JL, Swank SM, Furumasu J, Warath SL. Surgical and functional results of spine fusion in spinal muscular atrophy. Spine. 1989 Jul;14(7):763-70.

Daltroy LH, Liang MH, Fossel AH, Goldberg MJ. The POSNA pediatric musculoskeletal functional health questionnaire: report on reliability, validity, and sensitivity to change. Pediatric Outcomes Instrument Development Group. Pediatric Orthopaedic Society of North America. J Pediatr Orthop. 1998 Sep-Oct;18(5):561-71.

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.

Lancourt JE, Dickson JH, Carter RE. Paralytic spinal deformity following traumatic spinal-cord injury in children and adolescents. J Bone Joint Surg Am. 1981 Jan;63(1):47-53.

Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7.

Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7.

Mayfield JK, Erkkila JC, Winter RB. Spine deformity subsequent to acquired childhood spinal cord injury. J Bone Joint Surg Am. 1981 Dec;63(9):1401-11.

Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39.

Study ID Numbers:  9155-200513332
Last Updated:  April 18, 2007
Record first received:  November 16, 2005
ClinicalTrials.gov Identifier:  NCT00256672
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on June 12, 2007
Last Updated: 06/19/2007
What is This?

Related Articles on this Topic