Medical College of Wisconsin
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.
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.
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
SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
Standard of care Therapy without the use of trunk orthosis
Arctuva estimate
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