ViBandz Feasibility Study in the Neurological Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- End User System Usability Feedback on ViBandz
研究概览
简要总结
This is a single site, mixed methods, feasibility study of the ViBandz device at a Midwest pediatric tertiary care hospital in a physical and occupational therapy clinic.
详细描述
This proposal is for a single-site, feasibility study of the use of ViBandz in a treatment population. The analysis is a mixed methods approach with quantitative feedback on surveys and a secondary qualitative review of audio/+/- video that was obtained during the device use. The survey will be done immediately after the study on a device in clinic by the parents. If parents do not have time to finish it then, an email will be sent. Video and audio during the visit will provide additional rich data to understand the device beyond what a standard quantitative survey could provide. Subjects will have their standard clinical care- targeted vibration and then after their visit is completed, they will complete the use of the ViBandz This order will occur with all participants.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Children):
- •Children of ages 6 months to 17 years old
- •Neurologic conditions resulting in abnormal movement of at least one extremity
- •Appointment scheduled in CM PT/OT clinic that would include targeted focal vibration as a standard of care
排除标准
- •(Children):
- •Wards of the state
- •Inclusion Criteria (Parent/LAR):
- •Parent or Legally Authorized Representative of a child with inclusion criteria above
- •English-speaking
- •Exclusion Criteria (Parent/LAR):
- •Non-English speaking
结局指标
主要结局
End User System Usability Feedback on ViBandz
时间窗: 3-6 months
Overall themes to be investigated will include ease of use, perceived comfort in using the ViBandz in the home setting, suggestions for changes/improvements to the ViBandz, and any additional comments. This will be gathered through the use of the System Usability Survey that will be administered via REDCap to parents following use of the ViBandz device for targeted vibration therapy.
次要结局
未报告次要终点
研究者
Megan Blaufuss
Education Coordinator - PTOT
Children's Mercy Hospital Kansas City