Cerebral Palsy
Conditions
Keywords
abnormal muscle tone, cerebral palsy, hypotonia, muscle tone, spasticity
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 standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.
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
Sponsors
SPIO
Medical College of Wisconsin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in head and trunk position from centerline at baseline, 3-months and 6-months. | Through study completion, an average of 2 years | Degree change in head and trunk position from centerline as assessed by motion capture. |
| Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale. | Through study completion, an average of 2 years | The Pediatric Quality of Life Inventory Infant Scales (PedQL-I) is used to assess parent-reported health-related quality of life for children with ages 1-12 months or 12-24 months. It has the same five components, including physical functioning (6 items), physical symptoms (10 items), emotional functions (12 items), social functioning (4 items), and cognitive functioning (4 items) with scale from 0 to 4. 0 if it is never a problem 1. if it is almost never a problem 2. if it is sometimes a problem 3. if it is often a problem 4. if it is almost always a problem |
Countries
United States
Contacts
Primary ContactMitchell O'Neill, MD
Backup ContactSarah Golus
Outcome results
None listed