Clinical trial NCT04252196: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly.BAC.U
Official title: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Usability Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Bright Cloud International Corp
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-02-05
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device usability single group
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Subjective evaluation of medical device (custom questionnaire)
timeFrame: 4 weeks
measure: USE Questionnaire
timeFrame: 1 weeks
Secondary outcomes:
measure: Game errors
timeFrame: 4 weeks
measure: Game difficulty
timeFrame: 4 weeks
measure: Game scores
timeFrame: 4 weeks
measure: Level of comfort
timeFrame: 4 weeks
measure: Device ruggedness
timeFrame: 4 weeks
Other outcomes:
Locations:
city: North Brunswick
country: United States
facility: Commercialization Center for Innovative Technologies, Suite B203
state: New Jersey
Study officials:
References: