Acute StrokeNCT04724954
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)
A study of Acute Stroke, run by Bright Cloud International Corp at 2 sites in United States.
Trial summary
The research project is intended to provide information pertaining to the usability, feasibility and clinical benefit of the BAC system for early sub-acute post CVA rehabilitation, improved cognition and emotive state while in acute inpatient rehabilitation settings (Kessler Foundation) and in an outpatient clinic at… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Acute Stroke
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2019to 31 Dec 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;
- Healthy age-matched volunteers
- diagnosis of CVA that occurred more than 5 days prior and less than 21 days prior (for the stroke survivors group);
- English speakers;
- UE unilateral or bilateral involvement (from new bilateral CVA)
- motor involvement (FMA score 20 to 45);
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- ability to actively move UE more than 10o for shoulder and elbow flexion/extension;
- ability to actively extend fingers at least 5o
- cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30).
- The adaptive nature of BBC system hardware and therapeutic games can compensate for the motor limitations due to other co-morbidities. Therefore potential participants will not be excluded due to co-morbidities such as Parkinson or arthritis.
- Subjects may have normal cognition, MCI or dementia, since the games can compensate for diminished cognition through built-in cues and instructions.
- Inclusion Criterion for the controlled clinical trials arm at Kessler Foundation
- Living within 25 miles radius of Kessler Foundation West Orange location. This will facilitate participation in the outpatient clinic training, which follows inpatient rehabilitation.
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 enrolment
- Inability to actively extend fingers at least 5 degrees; v. 7/8/2018
- Fugl-Meyer scores of 19 or less;
- severe visual neglect or legally blind
Show all 18Show fewer
- 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 behaviour.
- inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).
- o Those living outside approximately 25 miles radius of Kessler Foundation West Orange location. Those living too far will have a harder time completing the study as outpatients, as they will probably choose clinics closer to home.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bright Cloud Int'l Corp
North Brunswick, New Jersey, 08902
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
The research project is intended to provide information pertaining to the usability, feasibility and clinical benefit of the BAC system for early sub-acute post CVA rehabilitation, improved cognition and emotive state while in acute inpatient rehabilitation settings (Kessler Foundation) and in an outpatient clinic at the same research hospital.
The randomised controlled trials will take place at Kessler Foundation (West Orange, NJ). It will develop a new longitudinal therapy for elderly stroke survivors who are inpatients and then outpatients at a regional rehabilitation hospital, by adding BAC training to customary care for both inpatients and outpatients. Two systems will be used, improving continuity of care (one each for inpatient and outpatient settings).
Read the detailed description
This study targets participants, who had suffered a stroke very recently, 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) bimanual rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities. The study also aims at determining benefit of continuum care training on the BAC in addition to conventional rehabilitation for participants who are inpatients and then outpatients at a rehabilitation hospital and clinic.
Specific aims are:
BAC technology acceptance (all groups); improved motor function for upper extremity; strengthening shoulder and fingers increased range of motion for arms and fingers; improved independence in activities of daily living; improved cognition; improved emotive state; reduction in perceived upper body pain.
Another component of the research project is a small pilot targeting individuals with Parkinson's disease. For them the project is going to:
determine technology acceptance when using the BrightBrainer system; benefit to arms motor function and strengthening when playing BCI therapeutic games; benefit to reduction or tremor when playing games; cognitive benefits improvement in their well-being.
- Conditions
- Acute Stroke
- Being tested
- Rehabilitation Therapy on Experimental Robotic Table and standard of care, Rehabilitation Therapy as part of Standard of Care (Control)
- Keywords
- acute stroke, sub-acute stage
- 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 on Experimental Robotic Table and standard of careDevice
Also called BrightArm Compact Rehabilitation
Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). They will also receive Standard of Care rehabilitation
Rehabilitation Therapy as part of Standard of Care (Control)Genetic
Control group will receive Standard of Care training only
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Therapy on Experimental Robotic Table and standard of care | Experimental | 10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited for experimental group.
The investigators will also recruit the 10 caregivers of the experimental subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states. Receives: Device: Rehabilitation Therapy on Experimental Robotic Table and standard of care |
| Rehabilitation Therapy as part of Standard of Care | Sham comparator | 10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited as a control group.
The investigators will also recruit the 10 caregivers of the control subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states. Receives: Genetic: Rehabilitation Therapy as part of Standard of Care (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment score for upper extremity function (UE sub-set)
Upper Extremity Mobility and function. It is scored from 0 (minimum score) to 66 (maximum). The higher the score, the better, with 66 indicating normal upper extremity function.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Cognitive executive function assessment score
Trail Making Test B (TMT-B), Neuropsychological Assessment Battery (NAB) Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function. No scale.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Secondary outcomes (14)
Change in Arm Range of Motion
Measurement of active movement range for shoulder, elbow, and wrist. Measured with a mechanical goniometer, higher angular values indicating larger movement range.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Grasp strength for whole hand (power grasp) and finger pinch
Grasp strength and pinch strength measurements using dynamo-meter and pinch meter, respectively. Measured three times for maximal exertion, then averaged. Higher values are better, indicating less hand weakness.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Finger Range of Motion measured with mechanical goniometer
finger extension/flexion range for proximal-metacarpal joints. Measured with mechanical goniometer
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Upper extremity functional index (UEFI-20) of independence in activities of daily living
Self report of degree of independence in activities of daily living (ADLs). Consists of 20 questions, each scored on a 5 point scale with 0 complete dependence (unable to perform task) to 4 independence in a tasks. Minimum score is 0 (subjects is unable to perform any of the 20 listed tasks to 80 complete independence in all 20 ADLs. Higher score is better outcome.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Stroke Impact Scale (SIS) measuring impact of stroke on independence in daily activities
Self report of degree of independence in activities of daily living (ADLs). Consists of questions, each scored on a 5 point Likert scale with 1 complete dependence (unable to perform task) to 5 independence in a tasks. Minimum score is 0 (subjects is unable to perform any of the 20 listed tasks to 80 complete independence in all 20 ADLs.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in CAHAI 9 Score of independence in bimanual ADLs
Chedoke Arm and Hand Activity Inventory, reflecting ADL independence in simulated bimanual ADLs. It consists of 9 tasks, each scored from 1 to 7, where 1 indicates need for total assistance (typical of very weak arms) to 7 indicating total independence in the task. Score range is 9 (minimum) to 63 (maximum)
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Game % Score (baseline and performance) in therapeutic games
BrightBrainer game performance %, with each game being scored individually. Scores converted to % of task achieved with range of 0% (worst outcome) to 100% (best outcomes).
Measured: through study completion, an average 5 weeks from enrollment
Game difficulty levels
BrightBrainer game difficulty settings, indicating game play intensity and challenge. Each game has levels from 1 (easiest) to 10 (hardest). Higher difficulty the subjects is able to play a game at represents a better outcome.
Measured: through study completion, an average 5 weeks from enrollment
Average game difficulty levels per session
BrightBrainer game difficulty averaged for all games played in a session. Higher average difficulty is indicative of higher function with 1 (easiest) to 10 (hardest). Higher average game difficulty represents a better outcome.
Measured: through study completion, an average 5 weeks from enrollment
Participants' feedback through subjective evaluation of the system
Subject feedback and overall ratings on BrightBrainer games, rated on a Likert scale with 1 being least desirable (strongly disagree) to 5 being most desirable rating (strongly agree).
Measured: at 3 weeks and at 5 weeks post enrollment
Change in Verbal attention as measured by the Neuropsychological Assessment Battery
Attention module digit span tests verbal attention when subject is spoken a sequence of digits, then asked to repeat that sequence. Subjects is spoken 10 sequences of increasing length of digits (between 1 and 9). Score is 1 if sequence is repeated correctly, 0 otherwise. Min score 0 means no spoken digit sequence was repeated correctly, 10 is maximum score, all sequences were repeated correctly by subject.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in visual attention as measured by Neuropsychological Assessment Battery
Visual attention measured with the dots test of the Neuropsychological Assessment Battery (NAB). This is a delayed recognition span paradigm, in which an array of dots is exposed for a brief period, followed by a blank interference page, followed by a new array with one additional dot. The subject needs to point to the "new" dot. Test administered 3 times, minimum score 0 (none of the new dots found) to maximum 3 (all 3 new dots found).
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity
participants' depression measure with higher scores indicating higher severity (worse mood). Score range is 0 to 63, with 0 indicating normal mood (no depression), 1-13 minimal depression, 14-19 mild depression, 20-28 for moderate and 29-63 severe depression.
Measured: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Caregiver evaluation of experimental system
Rating of system perceived benefit to the person the caregiver cares for. Rating uses a Likert scale with 1 being least desirable outcome and 5 most desirable one.
Measured: at 5 weeks from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Mar 2019
- Primary completion15 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Number of subjects: The Investigators expect to enroll up to 40 subjects, inpatients and then outpatients at a research hospital and its outpatient clinic at Kessler Foundation: 20 stroke patients, and 20 will be their spouses/caregivers of subjects participating in the randomized control trials component of this study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Cloud International Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kessler Foundation, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Grigore Burdea, Bright Cloud International Corp
- Investigators
- Grigore C Burdea, PhD, Study director, Bright Cloud International Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724954
- Sponsor's protocol ID
- Phase IIB Clinical Trial
- Other IDs
- R44AG044639
- Status last verified
- Jul 2021
- First submitted
- 12 Jan 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
- ClinicalTrials.gov ID
- NCT04724954
- Acronym / sponsor ID
- Phase IIB Clinical Trial
- Conditions
- Acute Stroke
- Keywords
- acute stroke, sub-acute stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bright Cloud International CorpIndustry (pharma, biotech, devices)
- Collaborators
- Kessler Foundation, National Institute on Aging (NIA)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 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 research project is intended to provide information pertaining to the usability, feasibility and clinical benefit of the BAC system for early sub-acute post CVA rehabilitation, improved cognition and emotive state while in acute inpatient rehabilitation settings (Kessler Foundation) and in an outpatient clinic at the same research hospital.
The randomised controlled trials will take place at Kessler Foundation (West Orange, NJ). It will develop a new longitudinal therapy for elderly stroke survivors who are inpatients and then outpatients at a regional rehabilitation hospital, by adding BAC training to customary care for both inpatients and outpatients. Two systems will be used, improving continuity of care (one each for inpatient and outpatient settings).
Detailed description
This study targets participants, who had suffered a stroke very recently, 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) bimanual rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities. The study also aims at determining benefit of continuum care training on the BAC in addition to conventional rehabilitation for participants who are inpatients and then outpatients at a rehabilitation hospital and clinic.
Specific aims are:
BAC technology acceptance (all groups); improved motor function for upper extremity; strengthening shoulder and fingers increased range of motion for arms and fingers; improved independence in activities of daily living; improved cognition; improved emotive state; reduction in perceived upper body pain.
Another component of the research project is a small pilot targeting individuals with Parkinson's disease. For them the project is going to:
determine technology acceptance when using the BrightBrainer system; benefit to arms motor function and strengthening when playing BCI therapeutic games; benefit to reduction or tremor when playing games; cognitive benefits improvement in their well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Number of subjects: The Investigators expect to enroll up to 40 subjects, inpatients and then outpatients at a research hospital and its outpatient clinic at Kessler Foundation: 20 stroke patients, and 20 will be their spouses/caregivers of subjects participating in the randomized control trials component of this study.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Therapy on Experimental Robotic Table and standard of care | Experimental | Device: Rehabilitation Therapy on Experimental Robotic Table and standard of care10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited for experimental group. The investigators will also recruit the 10 caregivers of the experimental subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states. |
| Rehabilitation Therapy as part of Standard of Care | Sham comparator | Genetic: Rehabilitation Therapy as part of Standard of Care (Control)10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited as a control group. The investigators will also recruit the 10 caregivers of the control subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 50 to 85;
- Healthy age-matched volunteers
- diagnosis of CVA that occurred more than 5 days prior and less than 21 days prior (for the stroke survivors group);
- English speakers;
- UE unilateral or bilateral involvement (from new bilateral CVA)
Key exclusion criteria (18 listed)
- o Those living outside approximately 25 miles radius of Kessler Foundation West Orange location. Those living too far will have a harder time completing the study as outpatients, as they will probably choose clinics closer to home.
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 on Experimental Robotic Table and standard of careAlso: BrightArm Compact RehabilitationExperimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). They will also receive Standard of Care rehabilitation | Device | Rehabilitation Therapy on Experimental Robotic Table and standard of care |
| Rehabilitation Therapy as part of Standard of Care (Control)Control group will receive Standard of Care training only | Genetic | Rehabilitation Therapy as part of Standard of Care |
Primary outcome
Change in Fugl-Meyer Assessment score for upper extremity function (UE sub-set)
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Upper Extremity Mobility and function. It is scored from 0 (minimum score) to 66 (maximum). The higher the score, the better, with 66 indicating normal upper extremity function.
Change in Cognitive executive function assessment score
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Trail Making Test B (TMT-B), Neuropsychological Assessment Battery (NAB) Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function. No scale.
14 secondary outcomes
Change in Arm Range of Motion
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Grasp strength for whole hand (power grasp) and finger pinch
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Finger Range of Motion measured with mechanical goniometer
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Upper extremity functional index (UEFI-20) of independence in activities of daily living
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Stroke Impact Scale (SIS) measuring impact of stroke on independence in daily activities
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in CAHAI 9 Score of independence in bimanual ADLs
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Game % Score (baseline and performance) in therapeutic games
Time frame: through study completion, an average 5 weeks from enrollment
Game difficulty levels
Time frame: through study completion, an average 5 weeks from enrollment
Average game difficulty levels per session
Time frame: through study completion, an average 5 weeks from enrollment
Participants' feedback through subjective evaluation of the system
Time frame: at 3 weeks and at 5 weeks post enrollment
Change in Verbal attention as measured by the Neuropsychological Assessment Battery
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in visual attention as measured by Neuropsychological Assessment Battery
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Caregiver evaluation of experimental system
Time frame: at 5 weeks from enrolment
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.
- BCI's corporate site showing therapeutic games used with the deviceLink 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, PhD study director
Bright Cloud International Corp
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Stroke, run by Bright Cloud International Corp at 2 sites 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 13 inclusion and 18 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 2 sites 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. Some participants in this study may receive a placebo. 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?
Change in Fugl-Meyer Assessment score for upper extremity function (UE sub-set) (time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment). 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.