Stroke SequelaeNCT04713384
Remote Bimanual Virtual Rehabilitation Post CVD
A study testing Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games in people with Stroke Sequelae and Cognitive Impairment, run by Grigore Burdea at 1 site in United States.
Trial summary
The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International… Read more about this study
- Who is it for?
- Ages 48 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Sequelae, Cognitive Impairment, Depression
- What is being tested?
- Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2015to 13 Sep 2018
- 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 48 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 48 to 80;
- Diagnosis of stroke which occurred more than 9 months prior (i.e. in the chronic phase);
- English speakers;
- UE unilateral motor involvement (FMA score 10 to 45);
- Be able to actively move UE more than 15 degrees for shoulder and for elbow flexion/extension;
- Be more than 4 months post casting procedures or Botulinum toxin injections;
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- Have cognitive skills to participate (Montreal Cognitive Assessment score 18-30).
- Potential participants will not be excluded due to co-morbidities such as Parkinson, frozen shoulder, or arthritis;
- Have normal cognition or MCI.
Who cannot join
- Be younger than 48 or older than 80;
- Present with severe visual neglect or legally blind;
- Have severe hearing loss or deafness;
- Present with receptive aphasia or severe expressive aphasia;
- Have uncontrolled hypertension (>190/100 mmHg);
- Have severe cognitive delay;
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- Cannot speak English;
- Have history of violence or drug abuse;
- Participants who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment will be excluded;
- Have severe hand spasticity and/or complete lack of arm movement;
- MoCA scores of 17 and below.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Bimanual Virtual Rehabilitation for Elderly With Cerebral Vascular Disease
The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);
Read the detailed description
8 elderly subjects (50 to 80 years old) who live at home and had a stroke more than 9 months prior to participation, who may also suffer from mild cognitive impairments and may be depressed, will be recruited. Their 8 caregivers will also be recruited at Kessler Foundation.
Participants will train on the BrightBrainer system for 4 weeks in their home, doing a total of 20 rehabilitation sessions. Sessions will consist of playing therapeutic games using both the impaired and unimpaired arms. Sessions will progress in duration from 20 minutes to 40 minutes of actual play. Before and after the 4 weeks home therapy, participants will travel to the Kessler Foundation (West Orange, NJ) and undergo standardized motor, cognitive, and emotive clinical evaluations.
- Conditions
- Stroke Sequelae, Cognitive Impairment, Depression
- Being tested
- Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games
- Keywords
- virtual reality, stroke, upper extremity, BrightBrainer, rehabilitation, home, gamification
- Medical subject headings
- Cognitive Dysfunction, Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic gamesDevice
Also called BrightBrainer using BrightBrainer Grasp therapeutic controller
20 sessions of playing therapeutic games using both arms while siting at a table at home. Arms hold either generic game controllers, or BrightBrainer therapeutic controllers. Sessions involve a variety of games that train motor and cognitive function in an integrative way. The games are rendered by the BrightBrainer system. Games adapt and are winnable, benefiting well-being (reducing depression). Each session may generate many hundreds of arm repetitions, finger movement and grasps, depending on session duration. Data on arm reach as well as game outcomes and vitals are uploaded to an secure server. These data allow researchers to remotely monitor compliance to protocol and longitudinal progress. Caregivers are present at each session, and provide feedback as well as subjective ratings of the system.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will undergo 4 weeks (20 sessions) of experimental rehabilitation in their home. They will play custom therapeutic games that are intensive and adapt to their condition. Before and after the 4-week intervention participants will travel to Kessler Foundation to undergo evaluations. The therapy is designed to improve arm range, strength, endurance, as well as memory, focusing and decision making. Data will be stored on the cloud, protected and monitored by the research team. Receives: Device: Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale)
Upper Extremity motor function Sub-Scale: 0 (completely impaired) to 66 (normal).
Measured: Change from baseline at 4 weeks
Trail Making Test B (TMT-B) (raw score) measure of cognitive executive function
Timed test measures the subject's executive function. Subject is asked to connect dots of a page (with associated digits) in increasing magnitude, in the shortest time. Less time (measured in seconds) is better.
Measured: Change from baseline at 4 weeks
Secondary outcomes (23)
Upper extremity functional index (UEFI) self-report of independence in daily activities
Self-report of Independence in activities of daily living (ADLs). Scale: 0 (complete lack of independence in performing a given ADLs) to 80 (completely independent in that task). The form reports on 20 ADLs, which the highest score being 4 on each of them. Thus the highest possible score is 80 (20x4).
Measured: Change from baseline at 4 weeks
Chedoke Arm and Hand Activity Inventory (CAHAI) 9 measure of independence in bimanual daily activities
ADL independence in bimanual tasks. Score Scale: 0 (completely impaired) to 63 (normal). Higher score is better, represented more independence in performing tasks with both hands.
Measured: Change from baseline at 4 weeks
Arm range of motion (degrees) measure for shoulder, elbow, wrist and fingers
Measurement of active movement range for shoulder, elbow and fingers. Subjects' arm range of motion in each kinematic angles are measured in degree using a goniometer. Larger number is better (more range of motion)
Measured: Change from baseline at 4 weeks
Shoulder strength for deltoid muscles
Measurement of shoulder strength using calibrated wrist weights. Subjects' shoulder strength is measured in pounds (lbs). More is better. 0 means no strength at all.
Measured: Change from baseline at 4 weeks
Grasp strength for power grasps and pinch grasps
Grasp strength and pinch strength measurements using dynamo-meter and pinch meter. Three readings are used for the dynamometer when subject is asked to exert maximum power grasp, and then averaged. More is better. Minimum score is 0 (no strength at all).
Measured: Change from baseline at 4 weeks
Neuropsychological Assessment Battery NAB Verbal and Visual Attention Module
Test for Verbal and visual attention will use Attention module digit span (working memory), dots (visual), which measures quantified metrics of subject's attention level. Dot test has a min of 0 (subject does not find the added dot) and a max of 12 (subject finds all added dots)
Measured: Change from baseline at 4 weeks
Trail Making Test A (TMT-A) measure of visual and cognitive processing speed
Timed test measures the subject's Processing speed - visual and cognitive processing speed. Less time is better (1 second)
Measured: Change from baseline at 4 weeks
Hopkins Verbal Learning Test, Revised (HVLT-R) measure of verbal, visual and memory
Tests measures the subject's verbal, visual and cognitive ability including delayed. Has 3 sub-tests plus a delayed recall test. Each sub-test has a min of 0 and a max of 12. Delayed recall has a min of 0 and a max of 24. More is better
Measured: Change from baseline at 4 weeks
Boston Naming Test (short form) test of verbal abbility in name (noun) associations
Test measures subject's verbal and cognitive ability by asking specific questions. Min score 0 (unable to answer any of 15 questions) max score 15 (answers all). More is better
Measured: Change from baseline at 4 weeks
Brief Visuospatial Memory Test-Revised (Raw score)
Timed Test of visuo-spatial memory by asking subjects to draw shapes they had seen. Higher score is better. Has alternate forms, only one form will be used in one evaluation.
Measured: 4 weeks
Beck Depression Inventory II measure of depression severity
Depression severity score (0 min, 63 max, less is better). 0 normal, 1-13 minimal; 14-19 Mild Depression; 20-28 Moderate Depression; 29-63 Severe Depression
Measured: Change from baseline at 4 weeks
Subjective evaluation by participant of the experimental therapy
Participant fills a custom questionnaire with 10 questions. Each question uses a 5-Point Likert scale the system ease of use, perceived benefits and technical issues. Scale (0: Strongly disagree, 4: Strongly agree. i.e., in favor of the system). Higher score is better. Maximum score if all are rated at strongly agree is 40.
Measured: 4 weeks
Blood Pressure measure by medical meter
Blood pressure taken at each session (needs to be within physiological limits). Blood pressure is measured at start, mid and end of session.
Measured: 4 weeks
Pulse measure by medical meter
Pulse taken at every session. Pulse is measured at start, mid and end of session.
Measured: 4 weeks
Arm Reach Baseline (computer measure)
Arm reach area (square inches) measured at start of session. Higher value of reach area is better.
Measured: 4 weeks
Session duration (computer measure)
Duration of exercises performed on the device during a session, measured in minutes by the computer. Minimum is 15 minutes, maximum is 40 minutes More is better.
Measured: 4 weeks
Average game scores (computer measure)
Average of scores achieved by a subjects when playing therapeutic games in a given session. The higher the average the better. Range is 1 (lowest difficulty) to 10 (highest difficulty).
Measured: 4 weeks
Arm repetitions (computer measure)
Computer measure of total arm repetitions done by the subject in the process of playing therapeutic games. The higher the number the better. Minimum is 0 meaning the subject had not mover either arm at all during the session.
Measured: 4 weeks
Finger extension repetitions (computer measure)
Computer measure of total finger extension repetitions done by the subject in the process of playing therapeutic games. The higher the number the better. Minimum is 0 meaning the subject had not opened either hand at all during the session.
Measured: 4 weeks
Grasping repetitions (computer measure)
Computer measure of total grasp repetitions done by the subject in the process of playing therapeutic games in a given session. When playing bimanually, the grasps by each hand are added in this measure. The higher the number the better. Minimum is 0 meaning the subject had not grasped at all during the session.
Measured: 4 weeks
Training intensity for arm and finger movements per minute (computer measure)
Computer measure of average number of arm repetitions and of finger movements or grasps done by a participant in 1 minute in the process of playing therapeutic games. The higher the number the better. Minimum is 0 meaning the participant had not played at all (had no repetitions during that session).
Measured: 4 weeks
Cognitive areas trained (computer measure)
Computer measure of minutes of specific cognitive area training during a session. Specific domains are Attention, Memory, Executive Function and Language. Minimum is 0 (that area was not trained in a session). Maximum is session duration (up to 40 minutes) when only one cognitive area was trained during a session.
Measured: 4 weeks
Average game level of difficulty (Computer Measure)
Computer measure of average game difficulty of all the games played by the subject in a give session. The higher the number the better. Minimum is 1 meaning the subject had played all the games at the lowest level of difficulty in that session. Maximum is 10 (all games were played at their highest level of difficulty).
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 posted19 Jan 2021
- Study start30 Sep 2015
- Primary completion31 Aug 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 elderly subjects. Or these 4 healthy age-matched volunteers for usability, and 8 elderly stroke survivors to determine technology acceptance and clinical benefit to motor, cognitive and emotive function, under remote rehabilitation conditions. We will also recruit their 8 caregivers so to have better feedback in changes they observe in the stroke survivors and any technology issues. Among them, one patient dropped, 7 patients (and their caregivers) completed the study. The subjects in this feasibility study will have UE motor impairments, normal cognition or have Mild Cognitive Impairment (MCI). Pre- and Post-intervention standardized evaluations will be used to determine benefit. Subjective evaluations and adherence to protocol will indicate acceptance of the technology. Each session of game exercises will store performance data, which will be monitored remotely.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore Burdea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kessler Foundation
- Responsible party
- Sponsor-investigator, Grigore Burdea, Bright Cloud International Corp
- Investigators
- AM Barrett, MD, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713384
- Sponsor's protocol ID
- Phase I Tele-Rehab
- Other IDs
- GRANT R43AG052290
- Status last verified
- Jul 2021
- First submitted
- 22 Jun 2018
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will publish group analysis data, or case data, but no individually identifiable data will be released, per Federal Regulations pertaining to Protected Health Information.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Bimanual Virtual Rehabilitation for Elderly With Cerebral Vascular Disease
- ClinicalTrials.gov ID
- NCT04713384
- Acronym / sponsor ID
- Phase I Tele-Rehab
- Conditions
- Stroke Sequelae, Cognitive Impairment, Depression
- Keywords
- virtual reality, stroke, upper extremity, BrightBrainer, rehabilitation, home, gamification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Grigore BurdeaIndustry (pharma, biotech, devices)
- Collaborators
- Kessler Foundation
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 19 Jan 2021 (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.
The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);
Detailed description
8 elderly subjects (50 to 80 years old) who live at home and had a stroke more than 9 months prior to participation, who may also suffer from mild cognitive impairments and may be depressed, will be recruited. Their 8 caregivers will also be recruited at Kessler Foundation.
Participants will train on the BrightBrainer system for 4 weeks in their home, doing a total of 20 rehabilitation sessions. Sessions will consist of playing therapeutic games using both the impaired and unimpaired arms. Sessions will progress in duration from 20 minutes to 40 minutes of actual play. Before and after the 4 weeks home therapy, participants will travel to the Kessler Foundation (West Orange, NJ) and undergo standardized motor, cognitive, and emotive clinical evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 elderly subjects. Or these 4 healthy age-matched volunteers for usability, and 8 elderly stroke survivors to determine technology acceptance and clinical benefit to motor, cognitive and emotive function, under remote rehabilitation conditions. We will also recruit their 8 caregivers so to have better feedback in changes they observe in the stroke survivors and any technology issues. Among them, one patient dropped, 7 patients (and their caregivers) completed the study. The subjects in this feasibility study will have UE motor impairments, normal cognition or have Mild Cognitive Impairment (MCI). Pre- and Post-intervention standardized evaluations will be used to determine benefit. Subjective evaluations and adherence to protocol will indicate acceptance of the technology. Each session of game exercises will store performance data, which will be monitored remotely.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic gamesParticipants will undergo 4 weeks (20 sessions) of experimental rehabilitation in their home. They will play custom therapeutic games that are intensive and adapt to their condition. Before and after the 4-week intervention participants will travel to Kessler Foundation to undergo evaluations. The therapy is designed to improve arm range, strength, endurance, as well as memory, focusing and decision making. Data will be stored on the cloud, protected and monitored by the research team. |
Who may qualify
- Ages
- 48 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 48 to 80;
- Diagnosis of stroke which occurred more than 9 months prior (i.e. in the chronic phase);
- English speakers;
- UE unilateral motor involvement (FMA score 10 to 45);
- Be able to actively move UE more than 15 degrees for shoulder and for elbow flexion/extension;
Key exclusion criteria (11 listed)
- Be younger than 48 or older than 80;
- Present with severe visual neglect or legally blind;
- Have severe hearing loss or deafness;
- Present with receptive aphasia or severe expressive aphasia;
- Have uncontrolled hypertension (>190/100 mmHg);
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 |
|---|---|---|
| Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic gamesAlso: BrightBrainer using BrightBrainer Grasp therapeutic controller20 sessions of playing therapeutic games using both arms while siting at a table at home. Arms hold either generic game controllers, or BrightBrainer therapeutic controllers. Sessions involve a variety of games that train motor and cognitive function in an integrative way. The games are rendered by the BrightBrainer system. Games adapt and are winnable, benefiting well-being (reducing depression). Each session may generate many hundreds of arm repetitions, finger movement and grasps, depending on session duration. Data on arm reach as well as game outcomes and vitals are uploaded to an secure server. These data allow researchers to remotely monitor compliance to protocol and longitudinal progress. Caregivers are present at each session, and provide feedback as well as subjective ratings of the system. | Device | Treatment |
Primary outcome
Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale)
Time frame: Change from baseline at 4 weeks
Upper Extremity motor function Sub-Scale: 0 (completely impaired) to 66 (normal).
Trail Making Test B (TMT-B) (raw score) measure of cognitive executive function
Time frame: Change from baseline at 4 weeks
Timed test measures the subject's executive function. Subject is asked to connect dots of a page (with associated digits) in increasing magnitude, in the shortest time. Less time (measured in seconds) is better.
23 secondary outcomes
Upper extremity functional index (UEFI) self-report of independence in daily activities
Time frame: Change from baseline at 4 weeks
Chedoke Arm and Hand Activity Inventory (CAHAI) 9 measure of independence in bimanual daily activities
Time frame: Change from baseline at 4 weeks
Arm range of motion (degrees) measure for shoulder, elbow, wrist and fingers
Time frame: Change from baseline at 4 weeks
Shoulder strength for deltoid muscles
Time frame: Change from baseline at 4 weeks
Grasp strength for power grasps and pinch grasps
Time frame: Change from baseline at 4 weeks
Neuropsychological Assessment Battery NAB Verbal and Visual Attention Module
Time frame: Change from baseline at 4 weeks
Trail Making Test A (TMT-A) measure of visual and cognitive processing speed
Time frame: Change from baseline at 4 weeks
Hopkins Verbal Learning Test, Revised (HVLT-R) measure of verbal, visual and memory
Time frame: Change from baseline at 4 weeks
Boston Naming Test (short form) test of verbal abbility in name (noun) associations
Time frame: Change from baseline at 4 weeks
Brief Visuospatial Memory Test-Revised (Raw score)
Time frame: 4 weeks
Beck Depression Inventory II measure of depression severity
Time frame: Change from baseline at 4 weeks
Subjective evaluation by participant of the experimental therapy
Time frame: 4 weeks
Blood Pressure measure by medical meter
Time frame: 4 weeks
Pulse measure by medical meter
Time frame: 4 weeks
Arm Reach Baseline (computer measure)
Time frame: 4 weeks
Session duration (computer measure)
Time frame: 4 weeks
Average game scores (computer measure)
Time frame: 4 weeks
Arm repetitions (computer measure)
Time frame: 4 weeks
Finger extension repetitions (computer measure)
Time frame: 4 weeks
Grasping repetitions (computer measure)
Time frame: 4 weeks
Training intensity for arm and finger movements per minute (computer measure)
Time frame: 4 weeks
Cognitive areas trained (computer measure)
Time frame: 4 weeks
Average game level of difficulty (Computer Measure)
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 21 Jul 2021.
- site showing deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will publish group analysis data, or case data, but no individually identifiable data will be released, per Federal Regulations pertaining to Protected Health Information.
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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.
AM Barrett, MD study director
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games in people with Stroke Sequelae and Cognitive Impairment, run by Grigore Burdea 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 9 inclusion and 11 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 21 Jul 2021. 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?
Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale) (time frame: Change from baseline at 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 21 Jul 2021.