Development of Innovative Strategies for the Control of Robotic Hand Prostheses Based on High-density Electromyography and Restitution of Sensory Feedback Via Trans-cutaneous Electrical Stimulation
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
- 2
- 主要终点
- Elicit somatic sensations in amputees
研究概览
简要总结
Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment during contact with objects. Therefore, it is important to develop bidirectional prostheses. It is thus apparent that the development of new techniques for decoding the efferent channel, such as high-density surface electromyography, and for encoding of the afferent channel afferent, to return multimodal somatosensory sensations of mechanoception, nociception, and thermoception using TENS, isimportant to improve the patient's use of the prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Upper limb amputation;
- •Stable clinical condition;
- •Skin integrity of the stump;
- •Age between 18 and 65 years;
- •High level of motivation to participate in the study and acceptance of the purpose of the study;
- •Signed informed consent document.
排除标准
- •Clinical instability;
- •Dehiscence of the amputation wound;
- •Failure to complete the informed consent;
- •State of pregnancy;
- •Implanted devices that can interfere with TENS stimulation (e.g. pacemakers);
结局指标
主要结局
Elicit somatic sensations in amputees
时间窗: through study completion, an average of 2 year through study completion, an average of 2 year
The performance of the stimulation strategy will be evaluated in terms of stimulus discrimination accuracy, a parameter that identifies the number of times the subject correctly reports the type of sensation elicited by the experimenter compared to the total number of stimulations performed.
Improve gestures decoding by means of HD-sEMG decoding algorithms
时间窗: through study completion, an average of 2 year through study completion, an average of 2 year
The performance of HD-sEMG classifiers with variable number of classes will be evaluated in the offline phase in terms of accuracy of classification and F1-Score.
次要结局
- Increase the number of hand grasps to be classfiied(through study completion, an average of 2 year through study completion, an average of 2 year)
- Development of encoding strategies(through study completion, an average of 2 year through study completion, an average of 2 year)