Actively Recruiting

Age: 6Months - 18Months
All Genders
NCT06027580

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

Age: 6Months - 18Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Medical College of Wisconsin/Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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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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