2 for Scoliosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ScoliosisThoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam - Device
Eligibility
5 - 16
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Scoliosis

Treatment Effectiveness

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 5 years

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

Trial Safety

Trial Design

2 Treatment Groups

2
1 of 2
1
1 of 2

Active Control

88 Total Participants · 2 Treatment Groups

Primary Treatment: 2 · No Placebo Group · N/A

2
Device
ActiveComparator Group · 1 Intervention: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam · Intervention Types: Device
1
Device
ActiveComparator Group · 1 Intervention: Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Shriners Hospitals for ChildrenLead Sponsor
95 Previous Clinical Trials
23,645 Total Patients Enrolled
8 Trials studying Scoliosis
1,460 Patients Enrolled for Scoliosis
Randal R Betz, MDPrincipal InvestigatorShriners Hospital for Children, Philadelphia
Lawrence Vogel, MDPrincipal InvestigatorShriners Hospital for Children, Chicago
Craig M McDonald, MDPrincipal InvestigatorShriners Hospital for Children, Northern California
1 Previous Clinical Trials
7 Total Patients Enrolled

Eligibility Criteria

Age 5 - 16 · All Participants · 6 Total Inclusion Criteria

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References