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

Primary Purpose

Scoliosis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Scoliosis focused on measuring Spinal Cord Injury, TLSO brace, Spine curvature, Child, Effectiveness of bracing

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

Shriners Hospital for Children - Northern California
Shriners Hospital for Children - Chicago
Shriners Hospital for Children - Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00256672

First Posted

November 16, 2005

Last Updated

June 11, 2008

Sponsor

Shriners Hospitals for Children

1. Study Identification

Unique Protocol Identification Number

NCT00256672

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2005 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shriners Hospitals for Children

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scoliosis

Keywords

Spinal Cord Injury, TLSO brace, Spine curvature, Child, Effectiveness of bracing

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

TLSO back brace, Flex-Foam (Posterior Opening)

Primary Outcome Measure Information:

Title

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

Time Frame

5 years

Title

Time Frame

5 years

Title

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.

Time Frame

5 years

Title

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.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig M McDonald, MD

Organizational Affiliation

Shriners Hospital for Children, Northern California

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Randal R Betz, MD

Organizational Affiliation

Shriners Hospital for Children, Philadelphia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lawrence Vogel, MD

Organizational Affiliation

Shriners Hospital for Children, Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shriners Hospital for Children - Northern California

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Shriners Hospital for Children - Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60707

Country

United States

Facility Name

Shriners Hospital for Children - Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

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Links:

URL

http://www.shrinershq.org

Description

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

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

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