Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
Medical College of Wisconsin
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.
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
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- No
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
- DeviceSPIO® Core-MAX® Expedition thoracolumbosacral orthosis
SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
- OtherStandard Care Therapy option
Standard of care Therapy without the use of trunk orthosis
Location
- Medical College of Wisconsin/Children's WisconsinMilwaukee, Wisconsin