Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Usability Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Subjective evaluation of medical device (custom questionnaire)
研究概览
简要总结
This usability study is to test the basic functionality of the BrightArm Compact (BAC) system. The BAC is a motorized rehabilitation platform to offer gravity bearing for weak upper extremity. It has a medical grade PC which hosts numerous interactive, adaptable computer games, played using BrightBrainer Grasp (BBG) controllers. The device is passive, in that no actuators apply forces on the patient. Further, the patient is free to lift that arm, nothing restricts the arms movement away from the BAC table.
详细描述
Healthy, age matched participants are invited to test the BAC at Bright Cloud Int Corporate Labs (675 US Hwy 1 south, B203, North Brunswick, NJ 08902, USA).
At the beginning of the usability training, participants will be required to sign a consent form, and BCI research staff will go over the details of the study and check inclusion criteria (generally healthy individual, age 50 ~ 85, English speaker, cognitively normal).
Subjects participate in 4 study sessions over approximately 1 month, each session lasting about an hour. The BAC table will have a different configuration each session. In the first session the table will have 0 tilt (flat). In session 2 it will be tilted 10 degrees downwards, in session 3 the table will be tilted up 10 degrees and in Session 4 the BAC table will be tilted up 20 degrees.
The difficulty of the games will also vary from session to session, progressing from the lowest difficulty in Session 1 to the highest difficulty in Session 4. Thus a given game will not be exactly the same, when played in a subsequent session, so to allow varying interaction scenarios.
At the end of each session, participants will be asked to fill up a custom feedback form. The custom form has questions on the system, the rehabilitation table, the controller, the therapeutic games they tested, and their overall impression of the experimental device. Each question on the custom form is answered on a 5-point Liker Scale.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy
- •age 50~80;
- •good or corrected vision;
- •good or corrected hearing
排除标准
- •motor or cognitively impaired;
- •outside 50~80 age bracket;
- •inability to speak English;
- •history of violence or drug abuse.
结局指标
主要结局
Subjective evaluation of medical device (custom questionnaire)
时间窗: 4 weeks
Custom questionnaire rating on a 5 point Likert scale. 1 (min), 5 (max), larger number means better outcomes
USE Questionnaire
时间窗: 1 weeks
Participants fill the standardized USE questionnaire rating the BrightArm Compact system on a 7-point Likert Scale. 1 (min), 7 (max), larger number means better outcomes.
次要结局
- Game difficulty(4 weeks)
- Game errors(4 weeks)
- Game scores(4 weeks)
- Level of comfort(4 weeks)
- Device ruggedness(4 weeks)
研究者
Dr. Nam H. Kim
Director of Engineering
Bright Cloud International Corp