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NCT00256672

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

Last Updated: 2008-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Scoliosis

Keywords

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Spinal Cord Injury TLSO brace Spine curvature Child Effectiveness of bracing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

High-dose Thoraco-Lumbar-Sacral Orthoses wear (\>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)

Group Type ACTIVE_COMPARATOR

Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

Intervention Type DEVICE

TLSO back brace, Flex-Foam (Posterior Opening)

2

Low-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)

Group Type ACTIVE_COMPARATOR

Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

Intervention Type DEVICE

TLSO back brace, Flex-Foam (Posterior Opening)

Interventions

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Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

TLSO back brace, Flex-Foam (Posterior Opening)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Shriners Hospital for Children

Principal Investigators

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Craig M McDonald, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children, Northern California

Randal R Betz, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children, Philadelphia

Lawrence Vogel, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children, Chicago

Locations

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Shriners Hospital for Children - Northern California

Sacramento, California, United States

Site Status

Shriners Hospital for Children - Chicago

Chicago, Illinois, United States

Site Status

Shriners Hospital for Children - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 11869904 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15218932 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12626930 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND

PMID: 2772729 (View on PubMed)

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

Reference Type BACKGROUND

PMID: 1192626 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 2312704 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12043927 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 7451526 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15456036 (View on PubMed)

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

Reference Type BACKGROUND

PMID: 3350947 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 6562445 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11805670 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10412999 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND

PMID: 7302685 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 7320032 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10786513 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15503701 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND

PMID: 10489007 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10404571 (View on PubMed)

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. doi: 10.1097/00004694-199809000-00001.

Reference Type BACKGROUND

PMID: 9746401 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND

PMID: 10104738 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10137673 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10024117 (View on PubMed)

Other Identifiers

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9155-200513332

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

2

Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

Interventions

Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Shriners Hospitals for Children

Responsible Party

Principal Investigators

Craig M McDonald, MD

Randal R Betz, MD

Lawrence Vogel, MD

Locations

Shriners Hospital for Children - Northern California

Shriners Hospital for Children - Chicago

Shriners Hospital for Children - Philadelphia

Countries

References

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.

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.

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.

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 (Phila Pa 1976). 1989 Jul;14(7):763-70. doi: 10.1097/00007632-198907000-00020.

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

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. doi: 10.1080/03093640208726622.

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 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.

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. doi: 10.1097/00006416-198311000-00003. 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 (Phila Pa 1976). 2002 Jan 15;27(2):211-4. doi: 10.1097/00007632-200201150-00018.

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.

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 (Phila Pa 1976). 1981 Sep-Oct;6(5):498-509. doi: 10.1097/00007632-198109000-00013.

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. doi: 10.1080/014608699265293.

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.

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.

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.

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.

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.

Related Links

Other Identifiers

9155-200513332