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| Name | Class |
|---|---|
| SPIO | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIO group | Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis |
| |
| Control group | Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPIO® Core-MAX® Expedition thoracolumbosacral orthosis | Device | SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in head and trunk position from centerline at baseline, 3-months and 6-months. | Degree change in head and trunk position from centerline as assessed by motion capture. | Through study completion, an average of 2 years |
| Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale. | 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
| Through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Children aged 6 months to 18 months age corrected with abnormal muscle tone assessed by a provider as likely to benefit from use of a compression garment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell O'Neill, MD | Contact | 414-266-4771 | moneill@mcw.edu | |
| Sarah Golus | Contact | 414-955-1923 | sgolus@mcw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell O'Neill, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin/Children's Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009123 | Muscle Hypotonia |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Standard Care Therapy option | Other | Standard of care Therapy without the use of trunk orthosis |
|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |