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

Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00256672
• Other study ID #: 9155-200513332
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2005
• Last updated: June 11, 2008
• Start date: June 2005
• Est. completion date: December 2012

Study information

• Verified date: June 2008
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: December 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Scoliosis
• Spinal Cord Injuries

Intervention

Device:
• Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
TLSO back brace, Flex-Foam (Posterior Opening)

Locations

Country	Name	City	State
United States	Shriners Hospital for Children - Chicago	Chicago	Illinois
United States	Shriners Hospital for Children - Philadelphia	Philadelphia	Pennsylvania
United States	Shriners Hospital for Children - Northern California	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (27)

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.

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

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. — View Citation

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 (Phila Pa 1976). 1999 Jul 1;24(13):1300-9. — View Citation

Brown JC, Zeller JL, Swank SM, Furumasu J, Warath SL. Surgical and functional results of spine fusion in spinal muscular atrophy. Spine (Phila Pa 1976). 1989 Jul;14(7):763-70. — View Citation

Campbell J, Bonnett C. Spinal cord injury in children. Clin Orthop Relat Res. 1975 Oct;(112):114-23. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Gurnham RB. Adolescent compliance with spinal brace wear. Orthop Nurs. 1983 Nov-Dec;2(6):13-7. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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.

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. — View Citation

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.

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. — View Citation

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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. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis.		5 years	No
Primary	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.		5 years	No
Primary	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.		5 years	No
Primary	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.		5 years	No

External Links

•   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