Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in head and trunk position from centerline at baseline, 3-months and 6-months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis (Device)
Control group
Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone
干预措施: Standard Care Therapy option (Other)
结局指标
主要结局
Change in head and trunk position from centerline at baseline, 3-months and 6-months.
时间窗: 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.
时间窗: 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
次要结局
未报告次要终点
研究者
Mitchell O'Neill
Assistant Professor
Medical College of Wisconsin