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临床试验/NCT04692571
NCT04692571已完成1 期

EMG-Based Hand-Wrist Control: Study B: Comparison of Contralateral (Mirrored) EMG-

Liberating Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月29日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
EMG-Force Models

研究概览

简要总结

Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects

详细描述

System identification models relating forearm electromyogram (EMG) signals to phantom wrist radial-ulnar deviation force, pronation-supination moment and/or hand open-close force (EMG-force) are hampered by lack of supervised force/moment output signals in limb-absent subjects. In able-bodied and unilateral transradial limb-absent subjects, we studied three alternative supervised output sources in one degree of freedom (DoF) and 2-DoF target tracking tasks: (1) bilateral tracking with force feedback from the contralateral side (non-dominant for able-bodied/ sound for limb-absent subjects) with the contralateral force as the output, (2) bilateral tracking with force feedback from the contralateral side with the target as the output, and (3) dominant/limb-absent side unilateral target tracking without feedback and the target used as the output.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Limb-absent subjects: unilateral trans-radial limb absence or amputation
  • •Be capable of completing the requested contractions on the affected dominant side

排除标准

  • •Past injuries to the upper limbs that would limit their ability to complete the requested contractions
  • •Scars that would impede the use of surface electrodes

研究组 & 干预措施

Study B: Limb-Absent Subject

Experimental

Ten unilateral transradial limb-absent subjects will each participate in one, half-day experimental session. Subjects will be seated and prepared in test apparatus seat (16 electrodes on the affected side, hand-wrist on the able side secured to load cells). Subjects will complete the 1-DoF and 2-DoF "dynamic" (force-varying) contractions (40-s duration, 0.75 Hz bandlimited, uniform random target). With 2 DoF contraction trials, hand Opn-Cls will always be one of the dimensions. The subject will then be released from the cuff and their able side not further involved in the experiment. The force feedback triangle cursor on the computer screen will be deleted such that only the target remains. Subjects will then repeat 1-DoF and 2-DoF trials in which the affected side attempts to produce hand-wrist effort that mimic movement of the target (with no feedback provided).

干预措施: PSICON Measurement Apparatus (Device)

Study B: Able-bodied Subjects

Experimental

Ten able-bodied subjects, the electrodes will be mounted on the dominant arm for the EMG-force and EMG-target tracking trials. In addition, the non-dominant arm will also be constrained and measured in a second load cell. This load cell will not be used for feedback during the experiment, but will compare (RMS error, off-line) the dominant vs. non-dominant forces. For EMG-target tracking, the dominant hand will remain in the wrist cuff (to prevent flailing during contractions), with the screen feedback disabled. These subjects will repeat the trials with the electrodes moved to the non-dominant side. EMG-force tracking will be repeated using mirrored contractions. The three training methods (EMG-force ipsilateral, EMG-force contralateral mirrored, EMG-target on the dominant side) will be contrasted to help understand the source of errors when training with limb-absent subjects.

干预措施: PSICON Measurement Apparatus (Device)

结局指标

主要结局

EMG-Force Models

时间窗: 1 day visit

Electromyogram waveform measurements (signal amplitude, frequency) will be related to force measurements (magnitude and moment) as related to the target tracking tasks. These signal-force data will be use to generate the models. The specific outcome for each subject will be the RMS error measured in the tracking tasks as the difference between the generated control signal from the user versus the prompted target signal, as measured by an EMG array.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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