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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: usability evaluation of medical device

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • North Brunswick, New Jersey, United States, 08902
      • Commercialization Center for Innovative Technologies, Suite B203

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bright Cloud International Corp
• Collaborators: National Institute on Aging (NIA)

Publications and helpful links

Helpful Links

• BCI's corporate site showing BrightArm device development

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2018
• Primary Completion (ACTUAL): January 28, 2019
• Study Completion (ACTUAL): January 28, 2019

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BCI-10-001.BAC.U; 5R44AG044639-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No