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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 2 | Active Comparator | Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam | Device | TLSO back brace, Flex-Foam (Posterior Opening) |
|
| Measure | Description | Time Frame |
|---|---|---|
| X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis. | 5 years | |
| 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 | |
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospital for Children - Northern California | Sacramento | California | 95817 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11869904 | Background | Rab G, Petuskey K, Bagley A. A method for determination of upper extremity kinematics. Gait Posture. 2002 Apr;15(2):113-9. doi: 10.1016/s0966-6362(01)00155-2. | |
| 15218932 | Background | 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. doi: 10.1109/TNSRE.2004.827222. |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D013119 | Spinal Cord Injuries |
| D013121 | Spinal Curvatures |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013118 | Spinal Cord Diseases |
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| Shriners Hospital for Children - Chicago |
| Chicago |
| Illinois |
| 60707 |
| United States |
| Shriners Hospital for Children - Philadelphia | Philadelphia | Pennsylvania | 19140 | United States |
| 12626930 | Background | 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. doi: 10.1097/01.BCR.0000054170.62555.09. |
| Background | Betz RR & Mulcahey MJ. Spinal Cord Injury Rehabilitation, In: The Pediatric Spine: Principles and Practice, S.L. Weinstein (eds). New York: Raven press, 1994. |
| 2772729 | Background | 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. doi: 10.1097/00007632-198907000-00020. |
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| 2312704 | Background | 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. |
| 12043927 | Background | 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. doi: 10.1080/03093640208726622. |
| 7451526 | Background | 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. |
| 15456036 | Background | Lou E, Raso J, Hill D, Durdle N, Mahood J, Moreau M. Brace monitoring system for the treatment of scoliosis. Stud Health Technol Inform. 2002;88:218-21. |
| 3350947 | Background | DiRaimondo CV, Green NE. Brace-wear compliance in patients with adolescent idiopathic scoliosis. J Pediatr Orthop. 1988 Mar-Apr;8(2):143-6. |
| 6562445 | Background | Gurnham RB. Adolescent compliance with spinal brace wear. Orthop Nurs. 1983 Nov-Dec;2(6):13-7. doi: 10.1097/00006416-198311000-00003. No abstract available. |
| 11805670 | Background | 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 (Phila Pa 1976). 2002 Jan 15;27(2):211-4. doi: 10.1097/00007632-200201150-00018. |
| 10412999 | Background | 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. doi: 10.1097/00004694-199907000-00013. |
| Background | 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. |
| 7302685 | Background | Mayfield JK. Severe spine deformity in myelodysplasia and sacral agenesis: an aggressive surgical approach. Spine (Phila Pa 1976). 1981 Sep-Oct;6(5):498-509. doi: 10.1097/00007632-198109000-00013. |
| 7320032 | Background | 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. |
| 10786513 | Background | 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. doi: 10.1080/014608699265293. |
| 15503701 | Background | 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. doi: 10.1080/10790268.2004.11753783. |
| Background | 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. |
| 10489007 | Background | 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. doi: 10.1016/s0003-9993(99)90059-x. |
| 10404571 | Background | 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. doi: 10.1097/00007632-199907010-00006. |
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| Background | 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. |
| 10104738 | Background | 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. doi: 10.1177/000841749005700207. |
| 10137673 | Background | 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. doi: 10.1177/000841749406100403. |
| 10024117 | Background | 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. doi: 10.1097/00005650-199902000-00003. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |