Orthosis to Improve Trunk Control in Infants Age 6-18 Months
NCT ID: NCT06027580
Last Updated: 2026-01-14
Study Results
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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RECRUITING
30 participants
OBSERVATIONAL
2024-02-21
2026-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SPIO group
Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
Control group
Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone
Standard Care Therapy option
Standard of care Therapy without the use of trunk orthosis
Interventions
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SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
Standard Care Therapy option
Standard of care Therapy without the use of trunk orthosis
Eligibility Criteria
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Inclusion Criteria
* No previous use of SPIO® or similar Lycra/compression garments
* Assessed by provider as likely to benefit from use of compression garment
Exclusion Criteria
* Inability for family to bring study subject to assessments
* Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period
* Botulinum toxin injections within 3 months, or during study participation
* Having prior orthopedic or neurosurgery surgeries within one year
6 Months
18 Months
ALL
No
Sponsors
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SPIO
UNKNOWN
Medical College of Wisconsin
OTHER
Responsible Party
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Mitchell O'Neill
Assistant Professor
Principal Investigators
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Mitchell O'Neill, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin/Children's Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO00048530
Identifier Type: -
Identifier Source: org_study_id
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