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Orthosis to Improve Trunk Control in Infants Age 6-18 Months

Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO

Who can join

6 Months – 18 Months · All sexes

Inclusion Criteria:

* Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone
* No previous use of SPIO® or similar Lycra/compression garments
* Assessed by provider as likely to benefit from use of compression garment

Exclusion Criteria:

* Non-English speaking
* 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

About the study

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.

What is being tested

• SPIO® Core-MAX® Expedition thoracolumbosacral orthosis (device)
• Standard Care Therapy option (other)

Sponsor: Medical College of Wisconsin · Participants: 30 · Started: Feb 21, 2024

Contact the study team

• Mitchell O'Neill, MD · Phone: 414-266-4771
• Sarah Golus · Phone: 414-955-1923

Official record on ClinicalTrials.gov — NCT06027580

Locations in the U.S.

Conditions

• Cerebral Palsy
• Muscle Spasticity

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.