Efficacy of Control System Adaptation in Improving Upper-Extremity Prosthetic Limb Wear Time in a Real-World Setting, a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Coapt, LLC
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Differences in prosthetic wear time
研究概览
简要总结
Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control. Conventional control systems require frequent recalibration in order to achieve consistent performance which can lead to prosthetic users choosing to wear their device less. This study investigates a new adaptive pattern recognition control algorithm that retrains, rather than overwrite, the existing control system each instance users recalibrate. The study hypothesis is that such adaptive control system will lead to more satisfactory prosthesis control thus reducing the need for recalibration and increasing how often users wear their device. Participants will wear their prosthesis as they would normally at-home using each control system (adaptive and non-adaptive) for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored during each period in order to compare user wear time and recalibration frequency when using adaptive or non-adaptive control. Participants will also play a set of virtual games on a computer at the start (0-months), mid-point (1-months) and end (2-months) of each period that will test their ability to control prosthesis movement using each control system. Changes in user performance will be evaluated during each period and compared between the two control systems. This study will not only evaluate the effectiveness of adaptive pattern recognition control, but it will be done at-home under typical and realistic prosthetic use conditions.
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
- Single (Participant)
盲法说明
Participants will not be explicitly informed which type of control they will be using during each 8-week period.
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 Gen 2).
- •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 in-home 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 in-home 8-week period. We will perform a statistical analysis to compare wear time when using each type of pattern recognition control system (adaptive and non-adaptive). We will complete repeated measures analysis of variance with subject as a random factor, order of control system used as a fixed variable, and wear time as a fixed variable.
次要结局
- Differences in calibration frequency(We will record calibration frequency during the course of each in-home 8-week period.)
- Changes in virtual game performance(Participants will complete the virtual games at the start (0-months), mid-point (1-months) and end (2-months) of each in-home 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. of each in-home 8-week period.)
- Prosthetic user survey(Participants will complete the survey at the end of their study participation (17 weeks).)
- Differences in classification accuracy(We will record classification accuracy at the start (0-months), mid-point (1-months) and end (2-months) of each in-home 8-week period.)