Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury - Full Text View

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

Genetics Home Reference related topics:

Scoliosis

MedlinePlus related topics:

Scoliosis Spinal Cord Injuries

U.S. FDA Resources

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. [ 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
1: Active Comparator 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)
2: Active Comparator 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:

Children with C5 to L2 SCI.
ASIA impairment levels A, B, or C.
Age greater than 5 up to one year before end of growth (14 in girls, 16 in boys)
A single structural curve <40 degrees or a double curve <40 degrees where the largest compensatory curve is <25 degrees on bending film.
Children at risk for Paralytic Scoliosis
Ability to follow simple instructions.

Exclusion Criteria:

Curve magnitude >40 degrees, pressure sores over the trunk.
Inability to tolerate TLSO wears.
Structural compensatory curves of 25 degrees or greater (double structural curves).
Severe Traumatic Brain Injury, TBI (8 and below on Glasgow Coma Scale).
Cognitive Impairment
Less than 6 months from date of injury

Contacts and Locations

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

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Shriners Hospital for Children ( Craig McDonald, MD, principal investigator )
Study ID Numbers:	9155-200513332
First Received:	November 16, 2005
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00256672
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

Study placed in the following topic categories:

Spinal Diseases

Spinal Cord Injuries

Scoliosis

Spinal Cord Diseases

Wounds and Injuries

Disease Progression

Neoplasm Metastasis

Central Nervous System Diseases

Trauma, Nervous System

Bone Diseases

Additional relevant MeSH terms:

Spinal Curvatures

Musculoskeletal Diseases

Nervous System Diseases

Disorders of Environmental Origin

ClinicalTrials.gov processed this record on July 03, 2008

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