RecruitingNot Applicable

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

United States30 participantsStarted 2024-02-21

Plain-language summary

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.

Who can participate

Age range6 Months – 18 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in head and trunk position from centerline at baseline, 3-months and 6-months.

Timeframe: Through study completion, an average of 2 years

Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.

Timeframe: Through study completion, an average of 2 years

Trial details

NCT IDNCT06027580

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-06

Contact for this trial

Mitchell O'Neill, MD

414-266-4771 moneill@mcw.edu

View on ClinicalTrials.gov More Cerebral Palsy trials