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 range

6 Months – 18 Months

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

6 Months – 18 Months

Sex

ALL

See this in plain English?

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

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