StrokeNCT04252170
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
A study testing Rehabilitation Therapy, Experimental on the BrightArm Compact device in people with Stroke, run by Bright Cloud International Corp at 1 site in United States.
Trial summary
The research project is intended to provide information pertaining to the feasibility of the BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral Vascular Accident. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation Therapy, Experimental on the BrightArm Compact device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2018to 31 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 85;
- diagnosis of first-time CVA that occurred more than 5 days prior and less than 21 days prior
- English speakers;
- UE unilateral or bilateral involvement (from new bilateral CVA)
- motor involvement (FMA score 20 to 45);
- ability to actively move UE more than 10 degrees for shoulder and elbow flexion/extension;
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- ability to actively extend fingers at least 5 degrees
- cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30).
- Subjects may have normal cognition, MCI or dementia
Who cannot join
- being younger than 50 or older than 85 years of age
- previous stroke
- Stroke that occurred more than 20 days prior to enrollment
- Inability to actively extend fingers at least 5 degrees;
- Fugl-Meyer scores of 19 or less;
- severe visual neglect or legally blind
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- severe hearing loss or deafness
- receptive aphasia or severe expressive aphasia;
- severe spasticity (Modified Ashworth Scale 4/4)
- contractures of the upper limb joints
- uncontrolled hypertension (>190/100 mmHg)
- severe cognitive impairment determined by Montreal Cognitive Assessment (MoCA) [Nasreddine et al, 2005] test of 9 and below;
- No chemodenervation or nerve block to upper limb involved during the experimental period (e.g., botulinum toxin injection)
- inability to speak English;
- a history of violence or drug abuse;
- paranoia and psychotic behavior;
- inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).
Trial locations and contacts
1 site in 1 country.
United States1 site
PowerBack Rehabilitation
Piscataway, New Jersey, 08854
About this study
Official title: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)
The research project is intended to provide information pertaining to the feasibility of the BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral Vascular Accident. The aims are to: a) determine clinical benefit to motor and cognitive function as well as mood; 2) to ascertain technology acceptance by patients and therapists. The experimental training consists of 12 integrative arm/hand and cognitive training by playing therapeutic games. Participants are evaluated pre-and post-intervention and provide subjective evaluation of the system.
Read the detailed description
This study targets participants, who had suffered a first stroke recently, and who may or may not have been diagnosed with mild cognitive impairments or dementia (including Alzheimer's disease). It is important to find out if these improvements can be obtained with the computer game-based integrative (motor-cognitive) bilateral rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities.
Specific aims are:
- BAC technology acceptance;
- improvement in motor function for the upper extremity;
- strengthening of shoulder and fingers;
- increased active (self initiated) range of motion for shoulder, arms and fingers;
- improved independence in activities of daily living;
- improvement in cognitive areas of memory, attention and decision making;
- improved mood (as in reduced depression severity);
- Conditions
- Stroke
- Being tested
- Rehabilitation Therapy, Experimental on the BrightArm Compact device
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Therapy, Experimental on the BrightArm Compact deviceDevice
Also called BrightArm Compact rehabilitation through games
Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). An Occupational Therapist will assist as needed.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility study, Stroke Survivors | Experimental | BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients. Receives: Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artificial Intelligence-determined game difficulty level
BrightBrainer game difficulty setting is determined based on patient's past performance, in order to adapt the therapy to a given individual. It representing an average or difficulties of all games played in a session. The measure implies game play intensity and level of challenge
Measured: Through study completion, an average of 3 weeks
Game Score (baseline and performance)
BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game.
Measured: Through study completion, an average of 3 weeks
Participants' feedback using 5-point Likert scale
Subjective evaluation feedback and overall ratings on BrightBrainer games. Consists of multiple questions, each ranked on a 5-point Likert scale, with 1 (min) and 5 (max).
Measured: Through study completion, an average of 3 weeks
Therapist subjective evaluation using 5-point Likert scale
Subjective evaluation given by the attending Occupational Therapist at the end of the experimental intervention. Multiple questions, each ranked from 1 (min) to 5 (max)
Measured: 3 weeks
Secondary outcomes (18)
Arm Range of Motion
measurement of active movement initiated by participant using a mechanical goniometer
Measured: Change from Baseline arm range of motion at 3 weeks
Finger Range of Motion
finger extension/flexion range using a mechanical goniomter
Measured: Change from Baseline finger range of motion at 3 weeks
Grasp Strength with Jamar Dynamo-meter
grasp strength measurement using dynamo-meter
Measured: Change from Baseline grasp strength at 3 weeks
Pinch strength with pinch meter
Pinch strength measured with fingers placed on a pinch meter
Measured: Change from Baseline at 3 weeks
Shoulder strength
Measurement of shoulder strength using calibrated wrist weights
Measured: Change from Baseline shoulder strength at 3 weeks
Fugl-Meyer Assessment (Upper Extremity sub-scale) score
Upper Extremity Motor function, score scale is 0 (min) to 66 (max). Larger score means better outcome.
Measured: Change from Baseline Fugl-Meyer Assessment Score at 3 weeks
Upper extremity functional index (UEFI) score
A self report of independence in 20 activities of daily living (ADLs). Total score range is 0 (min) to 80 (max). Larger score means better outcome.
Measured: Change from Baseline Upper Extremity Functional Inex score at 3 weeks
CAHAI 9 Score
Chedoke Arm and Hand Activity Inventory, reflecting ADL independence in simulated bimanual activities. Min score 9, max score 63, with larger score meaning better outcomes.
Measured: Change from Baseline CAHAI 9 score at 3 weeks
Jebsen Test of Hand Function
Timed test of 7 simulated activities of daily living. Lowest score is 0, largest score is 1260. Units are seconds. Lower score means better outcomes (faster completion).
Measured: Change from Baseline Jebsen Test of Hand Function score at 3 weeks
Beck Depression Inventory II (BDI II) score
participants' depression measure. Range is 0 (min) to 63 (max). Lower score indicate better outcomes (less depression).
Measured: Change from Baseline depression severity at 3 weeks
Verbal attention
Attention module digit span (working memory) in the Neuropsychological Assessment Battery NAB min 0, larger score is better
Measured: Change from Baseline verbal attention at 3 weeks
Verbal fluency
verbal fluency test min 0, larger score is better
Measured: Change from Baseline verbal fluency at 3 weeks
Verbal memory
Hopkins Verbal Learning Test, Revised (HVLT-R) min 0, larger is better
Measured: Change from Baseline verbal learning memory at 3 weeks
Brief Visuospatial Memory Test-Revised
A measure of memory function min 50 std of 10, larger score is better
Measured: Change from Baseline visuospatial memory at 3 weeks
Executive Function Module
Word Generation min 0, larger is better
Measured: Change from Baseline executive function at 3 weeks
Cognitive executive function
Trail Making Test B (TMT-B) lMin 50, std of 10, larger number means better outcomes
Measured: Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks
Cognitive executive function
NAB Executive Functioning Module min 50, std is 10, larger number means better outcomes
Measured: Change from Baseline NAB Exec Score at 3 weeks
Visual attention
Attention module dots (visual) in the Neuropsychological Assessment Battery NAB
Measured: Change from Baseline visual attention at 3 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 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Cloud International Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Genesis HealthCare System
- Responsible party
- Principal investigator, Dr. Nam H. Kim, Bright Cloud International Corp
- Investigators
- Grigore C Burdea, Ph.D., Study chair, BRIGHT CLOUD INTL CORP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252170
- Sponsor's protocol ID
- BCI-10-001
- 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
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Burdea G, Kim N, Polistico K, Kadaru A, Grampurohit N, Hundal J, Pollack S. Robotic Table and Serious Games for Integrative Rehabilitation in the Early Poststroke Phase: Two Case Reports. JMIR Rehabil Assist Technol. 2022 Apr 13;9(2):e26990. doi: 10.2196/26990.
PubMed 35416787
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 (Feasibility Study)
- ClinicalTrials.gov ID
- NCT04252170
- Acronym / sponsor ID
- BCI-10-001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Bright Cloud International CorpIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Genesis HealthCare System
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 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.
The research project is intended to provide information pertaining to the feasibility of the BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral Vascular Accident. The aims are to: a) determine clinical benefit to motor and cognitive function as well as mood; 2) to ascertain technology acceptance by patients and therapists. The experimental training consists of 12 integrative arm/hand and cognitive training by playing therapeutic games. Participants are evaluated pre-and post-intervention and provide subjective evaluation of the system.
Detailed description
This study targets participants, who had suffered a first stroke recently, and who may or may not have been diagnosed with mild cognitive impairments or dementia (including Alzheimer's disease). It is important to find out if these improvements can be obtained with the computer game-based integrative (motor-cognitive) bilateral rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities.
Specific aims are:
- BAC technology acceptance;
- improvement in motor function for the upper extremity;
- strengthening of shoulder and fingers;
- increased active (self initiated) range of motion for shoulder, arms and fingers;
- improved independence in activities of daily living;
- improvement in cognitive areas of memory, attention and decision making;
- improved mood (as in reduced depression severity);
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.
| Arm | Type | Receives |
|---|---|---|
| Feasibility study, Stroke Survivors | Experimental | Device: Rehabilitation Therapy, Experimental on the BrightArm Compact deviceBAC feasibility study at PowerBack, Piscataway NJ, with stroke patients. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 50 to 85;
- diagnosis of first-time CVA that occurred more than 5 days prior and less than 21 days prior
- English speakers;
- UE unilateral or bilateral involvement (from new bilateral CVA)
- motor involvement (FMA score 20 to 45);
Key exclusion criteria (17 listed)
- being younger than 50 or older than 85 years of age
- previous stroke
- Stroke that occurred more than 20 days prior to enrollment
- Inability to actively extend fingers at least 5 degrees;
- Fugl-Meyer scores of 19 or less;
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 |
|---|---|---|
| Rehabilitation Therapy, Experimental on the BrightArm Compact deviceAlso: BrightArm Compact rehabilitation through gamesExperimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). An Occupational Therapist will assist as needed. | Device | Feasibility study, Stroke Survivors |
Primary outcome
Artificial Intelligence-determined game difficulty level
Time frame: Through study completion, an average of 3 weeks
BrightBrainer game difficulty setting is determined based on patient's past performance, in order to adapt the therapy to a given individual. It representing an average or difficulties of all games played in a session. The measure implies game play intensity and level of challenge
Game Score (baseline and performance)
Time frame: Through study completion, an average of 3 weeks
BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game.
Participants' feedback using 5-point Likert scale
Time frame: Through study completion, an average of 3 weeks
Subjective evaluation feedback and overall ratings on BrightBrainer games. Consists of multiple questions, each ranked on a 5-point Likert scale, with 1 (min) and 5 (max).
Therapist subjective evaluation using 5-point Likert scale
Time frame: 3 weeks
Subjective evaluation given by the attending Occupational Therapist at the end of the experimental intervention. Multiple questions, each ranked from 1 (min) to 5 (max)
18 secondary outcomes
Arm Range of Motion
Time frame: Change from Baseline arm range of motion at 3 weeks
Finger Range of Motion
Time frame: Change from Baseline finger range of motion at 3 weeks
Grasp Strength with Jamar Dynamo-meter
Time frame: Change from Baseline grasp strength at 3 weeks
Pinch strength with pinch meter
Time frame: Change from Baseline at 3 weeks
Shoulder strength
Time frame: Change from Baseline shoulder strength at 3 weeks
Fugl-Meyer Assessment (Upper Extremity sub-scale) score
Time frame: Change from Baseline Fugl-Meyer Assessment Score at 3 weeks
Upper extremity functional index (UEFI) score
Time frame: Change from Baseline Upper Extremity Functional Inex score at 3 weeks
CAHAI 9 Score
Time frame: Change from Baseline CAHAI 9 score at 3 weeks
Jebsen Test of Hand Function
Time frame: Change from Baseline Jebsen Test of Hand Function score at 3 weeks
Beck Depression Inventory II (BDI II) score
Time frame: Change from Baseline depression severity at 3 weeks
Verbal attention
Time frame: Change from Baseline verbal attention at 3 weeks
Verbal fluency
Time frame: Change from Baseline verbal fluency at 3 weeks
Verbal memory
Time frame: Change from Baseline verbal learning memory at 3 weeks
Brief Visuospatial Memory Test-Revised
Time frame: Change from Baseline visuospatial memory at 3 weeks
Executive Function Module
Time frame: Change from Baseline executive function at 3 weeks
Cognitive executive function
Time frame: Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks
Cognitive executive function
Time frame: Change from Baseline NAB Exec Score at 3 weeks
Visual attention
Time frame: Change from Baseline visual attention at 3 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.
- Derived from this study: PubMed 35416787Burdea G, Kim N, Polistico K, Kadaru A, Grampurohit N, Hundal J, Pollack S. Robotic Table and Serious Games for Integrative Rehabilitation in the Early Poststroke Phase: Two Case Reports. JMIR Rehabil Assist Technol. 2022 Apr 13;9(2):e26990. doi: 10.2196/26990.
- BCI's corporate siteLink 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.
Grigore C Burdea, Ph.D. study chair
BRIGHT CLOUD INTL CORP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Therapy, Experimental on the BrightArm Compact device in people with Stroke, 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 9 inclusion and 17 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?
Artificial Intelligence-determined game difficulty level (time frame: Through study completion, an average of 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252170, which also lists 1 linked publication.
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.