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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: usability evaluation of medical device

• Registration Number: NCT04252196
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-08-15
• Primary Completion: 2019-01-28
• Study Completion: 2019-01-28
• Status Verified: 2020-01
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Usability Study	usability evaluation of medical device	Usability evaluators of medical device (Healthy volunteers).

Primary Outcome Measures

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

Name	Time	Method
Game difficulty	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 errors	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 scores	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	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	4 weeks	Participants play a number of custom, adaptable therapeutic games, at varying device configuration and report on frequency of technical issues (free form).

Trial Locations

Locations (1)

Commercialization Center for Innovative Technologies, Suite B203; 🇺🇸 North Brunswick, New Jersey, United States