Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly.BAC.U
|ClinicalTrials.gov Identifier: NCT04252196|
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: usability evaluation of medical device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Device usability single group|
|Masking:||None (Open Label)|
|Official Title:||Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Usability Study)|
|Actual Study Start Date :||August 15, 2018|
|Actual Primary Completion Date :||January 28, 2019|
|Actual Study Completion Date :||January 28, 2019|
Experimental: Device Usability Study
Usability evaluators of medical device (Healthy volunteers).
Device: usability evaluation of medical device
participants interact with medical device and rate it for usability
- 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.
- Game errors [ Time Frame: 4 weeks ]Participants play a number of custom, adaptable therapeutic games, and their errors are stored. Min number is 0, which is also the best outcome.
- Game difficulty [ Time Frame: 4 weeks ]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
- Game scores [ Time Frame: 4 weeks ]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.
- Level of comfort [ Time Frame: 4 weeks ]Participants play a number of custom, adaptable therapeutic games, at varying device configuration and report on perceived level of comfort (free form).
- Device ruggedness [ Time Frame: 4 weeks ]Participants play a number of custom, adaptable therapeutic games, at varying device configuration and report on frequency of technical issues (free form).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252196
|United States, New Jersey|
|Commercialization Center for Innovative Technologies, Suite B203|
|North Brunswick, New Jersey, United States, 08902|