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

Recruiting now

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT06027580

Run by

Medical College of Wisconsin

People needed

30

Starts

2024-02-21

Expected to finish

2026-08-06

Last updated by the study team

2026-01-14

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical College of Wisconsin/Children's Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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