NCT06446037已完成早期 1 期
Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Gesture accuracy
研究概览
简要总结
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
详细描述
The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals 21 years in age and older
- •Individuals with amputation of one or both arms at transradial level (applies to amputees only)
- •Ability to follow study directions
- •Willingness and ability to sign Informed Consent
排除标准
- •Individuals with previously diagnosed muscle pathologies
- •Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)
- •Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
- •Cognitively impaired to follow study instructions
- •Allergies to skin adhesive materials necessary for cutaneous electrode placement
- •Excessive hair growth on arms and inability to shave off the hair for electrode placement
- •Pregnant woman
- •Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays
- •Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study
结局指标
主要结局
Gesture accuracy
时间窗: Acute visit (at most 3 hours)
Percentage of hand gestures accurately decoded by Phantom X algorithm
次要结局
未报告次要终点
研究者
研究点 (2)
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