NCT06027580Recruiting
Orthosis to Improve Trunk Control in Infants Age 6-18 Months
Medical College of Wisconsin
Start Date
2/21/2024
Completion Date
8/6/2026
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 standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.
Eligibility Criteria
Age Range: No minimum to No maximum
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
Interventions
DEVICE
SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
OTHER
Standard Care Therapy option
Conditions
Cerebral Palsy
Locations
Medical College of Wisconsin/Children's Wisconsin
Milwaukee, Wisconsin 53226
United States