Actively Recruiting
Orthosis to Improve Trunk Control in Infants Age 6-18 Months
Led by Medical College of Wisconsin · Updated on 2026-01-14
30
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
M
Medical College of Wisconsin
Lead Sponsor
S
SPIO
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.
CONDITIONS
Official Title
Orthosis to Improve Trunk Control in Infants Age 6-18 Months
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Study subjects aged 6 months to 18 months with abnormal muscle tone
- No previous use of SPIO4 or similar Lycra/compression garments
- Assessed by provider as likely to benefit from use of compression garment
You will not qualify if you...
- Non-English speaking
- Family unable to bring study subject to assessments
- Use of orthosis or casting that prevent SPIO4 Core-MAX4 use during the study
- Botulinum toxin injections within 3 months before or during study
- Prior orthopedic or neurosurgery surgeries within one year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical College of Wisconsin/Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Mitchell O'Neill, MD
CONTACT
S
Sarah Golus
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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