HealthyNCT04252196
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly.BAC.U
A study testing usability evaluation of medical device in people with Healthy, run by Bright Cloud International Corp at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- usability evaluation of medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy
- age 50~80;
- good or corrected vision;
- good or corrected hearing
Who cannot join
- motor or cognitively impaired;
- outside 50~80 age bracket;
- inability to speak English;
- history of violence or drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Commercialization Center for Innovative Technologies, Suite B203
North Brunswick, New Jersey, 08902
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- usability evaluation of medical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usability evaluation of medical deviceDevice
participants interact with medical device and rate it for usability
| Study group | Role | What they receive |
|---|---|---|
| Device Usability Study | Experimental | Usability evaluators of medical device (Healthy volunteers). Receives: Device: usability evaluation of medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 weeks
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Aug 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device usability single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Cloud International Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Dr. Nam H. Kim, Bright Cloud International Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252196
- Sponsor's protocol ID
- BCI-10-001.BAC.U
- Other IDs
- 5R44AG044639-05
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Usability Study)
- ClinicalTrials.gov ID
- NCT04252196
- Acronym / sponsor ID
- BCI-10-001.BAC.U
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bright Cloud International CorpIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device usability single group
| Arm | Type | Receives |
|---|---|---|
| Device Usability Study | Experimental | Device: usability evaluation of medical deviceUsability evaluators of medical device (Healthy volunteers). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- generally healthy
- age 50~80;
- good or corrected vision;
- good or corrected hearing
Key exclusion criteria (4 listed)
- motor or cognitively impaired;
- outside 50~80 age bracket;
- inability to speak English;
- history of violence or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usability evaluation of medical deviceparticipants interact with medical device and rate it for usability | Device | Device Usability Study |
Primary outcome
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
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.
5 secondary outcomes
Game errors
Time frame: 4 weeks
Game difficulty
Time frame: 4 weeks
Game scores
Time frame: 4 weeks
Level of comfort
Time frame: 4 weeks
Device ruggedness
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- BCI's corporate site showing BrightArm device developmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usability evaluation of medical device in people with Healthy, run by Bright Cloud International Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective evaluation of medical device (custom questionnaire) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.