Clinical Feasibility of the IMES Transradial Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Grip Accuracy
研究概览
简要总结
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis
详细描述
The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.
Following a two-week recovery from implantation of up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(unilateral acquired transradial) amputation
- •residual limb size requirements to fit investigational device componentry
- •at least 6 residual muscle locations available for implantation
- •good compliance with health service (rehabilitation)
- •willing to undergo surgical implantation of IMES Sensor implants
- •experience with myoelectric upper limb prostheses
- •using own myoelectric device approximately 6-8h/day
- •able to provide informed consent and attend the study visits
排除标准
- •any condition which in the opinion of the investigator poses a risk to health
- •neurological disorder that may prohibit accurate control
- •major injury proximal to the level of amputation
- •neuromuscular disorder
- •nerve transection or palsy that may cause de-innervation of muscles planned for implantation
- •allergy to implanted materials
- •existing active implant
结局指标
主要结局
Grip Accuracy
时间窗: The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months.
Self-drafted assessment of accuracy in prosthesis movements. The purpose of this measure is to quantify subjects' ability to use the investigational device to control specific prosthetic movements. When performing the Accuracy Test, the subject attempts to execute a series of specified wrist and hand movements using the investigational device. An objective rater scores each movement on a 0-3 scale with 0 = no movement observed and and 3 = movement observed (with no unintended movements). A score is given for each movement and a combined score is derived from the complete set of movements. Administered as a repeated measure, the Grip Accuracy test assesses Change over time (training effect).
次要结局
未报告次要终点