NCT04252196

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly.BAC.U

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Usability Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bright Cloud International Corp · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	usability evaluation of medical device	participants interact with medical device and rate it for usability

Timeline

• Start date: 2018-08-15
• Primary completion: 2019-01-28
• Completion: 2019-01-28
• First posted: 2020-02-05
• Last updated: 2020-02-05

Locations

1 site across 1 country: United States