NCT04252196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 22, 2020

Last Update Submit

January 30, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Game errors

    4 weeks

  • Game difficulty

    4 weeks

  • Game scores

    4 weeks

  • Level of comfort

    4 weeks

  • Device ruggedness

    4 weeks

Study Arms (1)

Device Usability Study

EXPERIMENTAL

Usability evaluators of medical device (Healthy volunteers).

Device: usability evaluation of medical device

Interventions

usability evaluation of medical deviceDEVICE

participants interact with medical device and rate it for usability

Device Usability Study

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • generally healthy
  • age 50\~80;
  • good or corrected vision;
  • good or corrected hearing

You may not qualify if:

  • motor or cognitively impaired;
  • outside 50\~80 age bracket;
  • inability to speak English;
  • history of violence or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Commercialization Center for Innovative Technologies, Suite B203

North Brunswick, New Jersey, 08902, United States

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Device usability single group
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Engineering

Study Record Dates

First Submitted

January 22, 2020

First Posted

February 5, 2020

Study Start

August 15, 2018

Primary Completion

January 28, 2019

Study Completion

January 28, 2019

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)