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ScoliosisNCT00256672

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

A study testing Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam in people with Scoliosis, run by Shriners Hospitals for Children at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 16 years
Conditions the study is for
Scoliosis
What is being tested?
Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
3 sitesUnited States
Study dates
Jun 2005to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Shriners Hospital for Children - Chicago

    Chicago, Illinois, 60707

  • Shriners Hospital for Children - Philadelphia

    Philadelphia, Pennsylvania, 19140

  • Shriners Hospital for Children - Northern California

    Sacramento, California, 95817

Other trials in United States

About this 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

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.

Read the 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.

Conditions
Scoliosis
Being tested
Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
Keywords
Spinal Cord Injury, TLSO brace, Spine curvature, Child, Effectiveness of bracing
Medical subject headings
Scoliosis, Spinal Cord Injuries, Spinal Curvatures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-FoamDevice

    TLSO back brace, Flex-Foam (Posterior Opening)

Study groups in NCT00256672
Study groupRoleWhat they receive
1Active comparatorHigh-dose Thoraco-Lumbar-Sacral Orthoses wear (>23hrs/day) will be compared to low-dose Thoraco-Lumbar-Sacral Orthoses wear (12hrs/day)
Receives: Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam
2Active comparatorLow-dose Thoraco-Lumbar-Sacral-Orthoses wear (12hrs/day)
Receives: Device: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00256672
Sponsor's protocol ID
9155-200513332
Status last verified
Jun 2008
First submitted
16 Nov 2005
Last updated
13 Jun 2008
Results posted
No

Publications

  • 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.

    PubMed 11869904

  • 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.

    PubMed 15218932

  • 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.

    PubMed 12626930

  • 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.

    PubMed 2772729

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

    PubMed 1192626

  • 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.

    PubMed 2312704

  • 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.

    PubMed 12043927

  • 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.

    PubMed 7451526

  • 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.

    PubMed 15456036

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

    PubMed 3350947

  • 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.

    PubMed 6562445

  • 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.

    PubMed 11805670

  • 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.

    PubMed 10412999

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam in people with Scoliosis, run by Shriners Hospitals for Children at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis. (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00256672, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2008.

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