To Validate Point Mini User Needs
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- VAL-3.1
研究概览
简要总结
The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial hand loss with at least index and/or middle fingers loss at the MCP level
- •Intact thumb with full range of motion
- •Fluent in English
- •Between the ages of 5 and 15 years
排除标准
- •Patients with a residual limb that is unhealed from the amputation surgery
- •Unhealed wounds
- •Significant cognitive deficits as determined upon clinical evaluation
- •Significant neurological deficits as determined upon clinical evaluation
- •Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- •Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
- •Serious uncontrolled medical problems as judged by the project therapist
研究组 & 干预措施
Prosthesis
Patient is temporarily fit with Point Mini finger prosthetic system
干预措施: Point Mini (Device)
结局指标
主要结局
VAL-3.1
时间窗: Day 1 (10 minutes)
User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail)
VAL-5
时间窗: Day 1 (10 minutes)
User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail)
VAL-6
时间窗: Day 1 (10 minutes)
User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail)
VAL-7
时间窗: Day 1 (10 minutes)
User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail)
VAL-8
时间窗: Day 1 (10 minutes)
User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail)
VAL-9
时间窗: Day 1 (8 hours)
User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail)
VAL-2
时间窗: Day 1 (10 minutes)
User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)
VAL-1
时间窗: Day 1 (8 hours)
User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)
VAL-4
时间窗: Day 1 (10 minutes)
User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail)
VAL-3.2
时间窗: Day 1 (10 minutes)
User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail)
次要结局
未报告次要终点