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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252196
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dr. Nam H. Kim, Bright Cloud International Corp

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.

Condition or disease Intervention/treatment Phase
Healthy Device: usability evaluation of medical device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Device usability single group
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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).

  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252196


Locations
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United States, New Jersey
Commercialization Center for Innovative Technologies, Suite B203
North Brunswick, New Jersey, United States, 08902
Sponsors and Collaborators
Bright Cloud International Corp
National Institute on Aging (NIA)
  Study Documents (Full-Text)

Documents provided by Dr. Nam H. Kim, Bright Cloud International Corp:
Informed Consent Form  [PDF] September 5, 2018
Study Protocol  [PDF] August 24, 2018

Additional Information:
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Responsible Party: Dr. Nam H. Kim, Director of Engineering, Bright Cloud International Corp
ClinicalTrials.gov Identifier: NCT04252196    
Other Study ID Numbers: BCI-10-001.BAC.U
5R44AG044639-05 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No