Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Usability Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Bright Cloud International Corp
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Subjective evaluation of medical device (custom questionnaire)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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. At the end of the last session they will fill a standardized USE form, with questions rated on a 7-point Likert scale. Feedback from participant will be used to improve the device as well as the therapeutic games.
Investigators
Dr. Nam H. Kim
Director of Engineering
Bright Cloud International Corp
Eligibility Criteria
Inclusion Criteria
- •generally healthy
- •age 50\~80;
- •good or corrected vision;
- •good or corrected hearing
Exclusion Criteria
- •motor or cognitively impaired;
- •outside 50\~80 age bracket;
- •inability to speak English;
- •history of violence or drug abuse.
Outcomes
Primary Outcomes
Subjective evaluation of medical device (custom questionnaire)
Time Frame: 4 weeks
Custom questionnaire rating on a 5 point Likert scale. 1 (min), 5 (max), larger number means better outcomes
USE Questionnaire
Time Frame: 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.
Secondary Outcomes
- Game difficulty(4 weeks)
- Game errors(4 weeks)
- Game scores(4 weeks)
- Level of comfort(4 weeks)
- Device ruggedness(4 weeks)