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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: usability evaluation of medical device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Device usability single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Usability Study<br>Usability evaluators of medical device (Healthy volunteers). | Device: usability evaluation of medical device<br>* participants interact with medical device and rate it for usability<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evaluation of medical device (custom questionnaire) | Custom questionnaire rating on a 5 point Likert scale. 1 (min), 5 (max), larger number means better outcomes | 4 weeks | 
| USE Questionnaire | 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. | 1 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Game errors | Participants play a number of custom, adaptable therapeutic games, and their errors are stored. Min number is 0, which is also the best outcome. | 4 weeks | 
| Game difficulty | Participants play a number of custom, adaptable therapeutic games, and their game difficulty level is stored each time. Min is 1, larger number is better | 4 weeks | 
| Game scores | Participants play a number of custom, adaptable therapeutic games, and their game scores are stored each time. Min score is 0, larger score is better. | 4 weeks | 
| Level of comfort | Participants play a number of custom, adaptable therapeutic games, at varying device configuration and report on perceived level of comfort (free form). | 4 weeks | 
| Device ruggedness | Participants play a number of custom, adaptable therapeutic games, at varying device configuration and report on frequency of technical issues (free form). | 4 weeks |