Peripheral Interfaces in Amputees for Sensorimotor Integration
概览
- 阶段
- 不适用
- 干预措施
- iSens
- 疾病 / 适应症
- Upper Extremity Amputee
- 发起方
- VA Office of Research and Development
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient Experience Measure
- 状态
- 招募中
- 最后更新
- 上个月
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.
研究者
入排标准
入选标准
- •Age 21 or greater
- •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
研究组 & 干预措施
iSens
3 months trial with the iSens system
干预措施: iSens
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)