Simultaneous Pattern Recognition Control of Powered Upper Limb Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Coapt, LLC
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Differences in prosthetic wear time
研究概览
简要总结
This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm function at a time, simultaneous control allows for more than one at the same time. Participants will wear their prosthesis as they would normally at home using each control style for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored; including, how often participants wear their device and how many times they move each degree of freedom independently or simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous control over conventional control which will result in wearing their device more often. The secondary hypothesis is that simultaneous control will result in more efficient prosthesis control which will make it easier for participants to perform activities of daily living. The results of this study will help identify important factors related to prosthetic users' preferences while freely wearing their device within their own daily-life environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have an upper-limb difference (congenital or acquired) at the transradial (between the wrist and elbow), elbow disarticulation (at the elbow), transhumeral (between the elbow and shoulder), or shoulder disarticulation (at the shoulder) level.
- •Subjects are suitable to be, or already are, a Coapt pattern recognition user (Coapt Complete Control Gen2 device).
- •Subjects are between the ages of 18 and 70.
排除标准
- •Subjects with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback discussion.
- •Subjects who are non-English speaking.
- •Subjects who are pregnant.
结局指标
主要结局
Differences in prosthetic wear time
时间窗: We will record total prosthetic wear time during the course of each 8-week period.
We will record each instance participants turn on or off their pattern recognition device throughout the home trial. Prosthetic wear time is defined as the cumulative amount of time participants keep their pattern recognition device turned on during the course of each 8-week period. We will perform a statistical analysis to compare wear time when using each type of pattern recognition control (simultaneous and seamless, sequential). We will complete a repeated measures analysis of variance with subject as a random factor, order of control style used as a fixed variable, and wear time as a fixed variable.
次要结局
- Changes in virtual game performance(Participants will complete the virtual test at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.)
- Differences in classification accuracy(We will record classification accuracy at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.)
- RIC's Orthotics Prosthetics User Survey(Participants will complete the OPUS at the start (0-months) and end (2-months) of each 8-week period.)