Status:
RECRUITING
Orthosis to Improve Trunk Control in Infants Age 6-18 Months
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
SPIO
Conditions:
Cerebral Palsy
Eligibility:
All Genders
6-18 years
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.
Detailed Description
This study will observe the difference in outcomes between two courses of standard clinical care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will self-select that standa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 6 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06027580
Start Date
February 21 2024
End Date
August 6 2026
Last Update
October 17 2025
Active Locations (1)
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1
Medical College of Wisconsin/Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226