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Completed

NCT Number: NCT04252196

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

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.

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Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Commercialization Center for Innovative Technologies, Suite B203

North Brunswick, New Jersey, 08902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

usability evaluation of medical device

Device

participants interact with medical device and rate it for usability

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Bright Cloud International Corp

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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