Overview
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.
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
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