NCT00256672

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

4.5 years

First QC Date

November 16, 2005

Last Update Submit

June 11, 2008

Conditions

Scoliosis

Keywords

Spinal Cord InjuryTLSO braceSpine curvatureChildEffectiveness of bracing

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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

2

ACTIVE COMPARATOR

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

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

Interventions

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

TLSO back brace, Flex-Foam (Posterior Opening)

12

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shriners Hospital for Children - Northern California

Sacramento, California, 95817, United States

Location

Shriners Hospital for Children - Chicago

Chicago, Illinois, 60707, United States

Location

Shriners Hospital for Children - Philadelphia

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (27)

  • 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.

    PMID: 11869904BACKGROUND

  • 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.

    PMID: 15218932BACKGROUND

  • 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.

    PMID: 12626930BACKGROUND

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

    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.

    PMID: 2772729BACKGROUND

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

    PMID: 1192626BACKGROUND

  • 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.

    PMID: 2312704BACKGROUND

  • 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.

    PMID: 12043927BACKGROUND

  • 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.

    PMID: 7451526BACKGROUND

  • 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.

    PMID: 15456036BACKGROUND

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

    PMID: 3350947BACKGROUND

  • 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.

    PMID: 6562445BACKGROUND

  • 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.

    PMID: 11805670BACKGROUND

  • 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.

    PMID: 10412999BACKGROUND

  • 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.

    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.

    PMID: 7302685BACKGROUND

  • 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.

    PMID: 7320032BACKGROUND

  • 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.

    PMID: 10786513BACKGROUND

  • 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.

    PMID: 15503701BACKGROUND

  • 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.

    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.

    PMID: 10489007BACKGROUND

  • 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.

    PMID: 10404571BACKGROUND

  • 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.

    PMID: 9746401BACKGROUND

  • 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.

    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.

    PMID: 10104738BACKGROUND

  • 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.

    PMID: 10137673BACKGROUND

  • 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.

    PMID: 10024117BACKGROUND

Related Links

MeSH Terms

Conditions

ScoliosisSpinal Cord InjuriesSpinal Curvatures

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2012

Last Updated

June 13, 2008

Record last verified: 2008-06

Locations

US(3)