NCT06027580 Orthosis to Improve Trunk Control in Infants Age 6-18 Months
| NCT ID | NCT06027580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2026-08-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-02-21 with a primary completion date of 2026-08-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Mitchell O'Neill, MD
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT06027580 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 18 Months, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06027580 currently recruiting?
Yes, NCT06027580 is actively recruiting participants. Contact the research team at moneill@mcw.edu for enrollment information.
Where is the NCT06027580 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT06027580 clinical trial?
NCT06027580 is sponsored by Medical College of Wisconsin. The principal investigator is Mitchell O'Neill, MD at Medical College of Wisconsin. The trial plans to enroll 30 participants.
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