Peripheral Interfaces in Amputees for Sensorimotor Integration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient Experience Measure
研究概览
简要总结
The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.
详细描述
The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessments will be analyzed by a blinded assessor.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acquired upper limb amputation
- •Unilateral or bilateral amputation, above or below elbow
- •At least 6 months since time of amputation
- •Current user of a myoelectric prosthesis or prescribed to use one
- •Viable target nerves in the upper extremity
- •Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
排除标准
- •A contraindication preventing surgery
- •Uncontrolled diabetes
- •Chronic skin ulcerations
- •History of poor wound healing without specific cause
- •History of uncontrolled infection without specific cause
- •Active infection
- •Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
- •Inability to speak English
- •Expectation that MRI will be required at any point for duration of study or while device is implanted.
- •Arthritis in the area of implant
- •Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
- •Presence of auto immune diseases, or conditions requiring immunosuppression.
研究组 & 干预措施
iSens
3 months trial with the iSens system
干预措施: iSens (Device)
State of the Art Prosthesis
3 months trial with their own prosthesis.
结局指标
主要结局
Patient Experience Measure
时间窗: 9 months post implant
Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome.
次要结局
- Modified Box and Blocks(9 months post implant)