Subacute StrokeSMARTERNCT06691880
Feasibility of Video Gaming Technology for Arm Recovery Early Post-stroke
A study testing MindPod Dolphin VGT and Bimanual Arm Trainer VGT in people with Subacute Stroke and Acute Stroke, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators are investigating ways to incorporate new technologies that can enhance functional outcome after neurological insult into the patient recovery space. In order to accelerate the translation of these technologies to patient care spaces, the investigators need to identify the locations that are feasible… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Subacute Stroke, Acute Stroke
- What is being tested?
- MindPod Dolphin VGT and Bimanual Arm Trainer VGT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2020to 1 Sep 2025
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Meyer 7 inpatient rehabilitation unit (CIIRP) or Zayed 12 West (12W) Brain Rescue Unit (BRU)
- Unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in MMT score from unaffected side to affected side)
Who cannot join
- Unable to sit upright for at least 3 minutes
- Unable to follow 1 step commands
- Vision impairment that impedes seeing the television screen
- Medical instability as defined by the care provider
- Orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity
- Heart condition that limits participation in exercise
- Active seizures or epilepsy
- Inability to communicate pain status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translating SMARTS 2: the Integration of Video Gaming Technology Into Traditional Rehabilitation
The investigators are investigating ways to incorporate new technologies that can enhance functional outcome after neurological insult into the patient recovery space. In order to accelerate the translation of these technologies to patient care spaces, the investigators need to identify the locations that are feasible for its use. Currently the investigators are using video game technologies that are used to maximize motor recovery of impaired upper extremities after neurological insult in the outpatient (clinic) setting. These technologies interface with robotics and other hardware to create a therapy experience that is fun, engaging, dynamic, challenging, and promotes repetitions that are otherwise difficult to achieve during conventional post-stroke rehabilitation. The investigators think early use of these technologies could enhance recovery of the arm, but It is not known if use of these technologies in the early post-stroke recovery period is safe and feasible.
Read the detailed description
This study explores a protocolized approach to high-dosed, video-game-based arm training in addition to standard of care rehabilitation in the acute/sub-acute phase of stroke recovery. Patients admitted to the Johns Hopkins Hospital rehabilitation unit or the Brain Rescue Unit with new unilateral upper limb weakness as a result of the patient's sequela will be considered for enrollment. Once consented, participants will be seen 4-5 days per week for up to 60 minutes of additional arm training using gaming technology. Participant response to training will be measured before and after the intervention and function and impairment level will be measured pre and post the training protocol. Participants will be expected to participate in the training protocol for the duration of the hospital stay.
The study involves patients who were already hospitalized at a large teaching institution in Maryland. Participants were screened for eligibility on admission to the hospital. If eligible, the patient was screened in person to determine if he/she was able to follow a 1 step functional command and for willingness to participate. Once agreeable, patients and/or the patient's surrogate decision makers were consented to enroll into the study. Patients were included if a stroke was confirmed by CT or MRI with subsequent unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in Manual Muscle Testing (MMT) score from unaffected side to affected side). Patients were excluded if unable to sit upright for at least 5 minutes in a chair without arm support, unable to follow 1 step functional commands or had a vision impairment that impeded seeing the television screen. Patients were also excluded if the patient had medical instability as defined by the care provider, orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity, heart conditions that limits participation in exercise, active seizures or epilepsy or the inability to communicate pain status.
Once consented, baseline assessments are administered and include the FM-UE and dynamometry. The patients are stratified to a gaming technology based on the baseline FM-UE score. Patients with a FM-UE less than 25 are placed in the Bimanual Arm Training group. During the treatment session, the patients are monitored for tolerance of the session using pre and post vitals including Blood Pressure, Heart Rate, and pulse oximetry. Pre/post pain and fatigue ratings are also maintained using a 10 point-likert scale. Trained clinicians gathered session start and end time. Technological difficulties and other interruptions are documented. Adverse events are gathered and include any swelling or bruising, cut/scratch/irritations, and new numbness or tingling. Intervention clinicians use a detailed stopping criteria to monitor the patient for tolerance and participation in the target time on task. The subjects receive intervention daily outside of the subject's regularly scheduled therapy for the 4-5 days a week (pending clinician availability) for the length of the hospital stay.
On the day of or day prior to discharge, FM-UE and dynamometry is gathered again. Qualitative post-intervention outcome measures are gathered for and included a survey of the patient's experience using a Likert-Scale based questionnaire, a Technology Acceptance Model survey (examines the patient's experience using technology and breaks it down into previously defined domains: Perceived Ease of Use (PEU), Perceived Usefulness (PU), Attitude Toward Using (ATU), Behavioral Intention to Use (BIU), and the Intrinsic Motivation Inventory (IMI).
- Conditions
- Subacute Stroke, Acute Stroke
- Being tested
- MindPod Dolphin VGT, Bimanual Arm Trainer VGT
- Keywords
- stroke, brain repair, recovery, video gaming, Implementation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindPod Dolphin VGTBehavioural
The MindPod Dolphin, is an interactive video game that allows users to engage in "non-task-based tasks" to motivate the users to play and relearn motor skills. The MindPod gaming platform uses markerless tracking to sense the patient's affected arm. The paretic limb controls Bandit the dolphin underwater in an effort to eat fish. The patient learns to map his/her movements to Bandit in a 3-Dimensional work space to reach the targets. During gaming, the therapist titrates game difficulty. Bilateral gaming components are used (the participant uses a controller with the participant's less-affected limb to control the timing of Bandit's movement) and in-game difficulty can be adjusted to create an immersive, challenging, and engaging experience. In order to be successful, the patient must coordinate both arms to control the temporal and spatial aspects of the game.
Bimanual Arm Trainer VGTBehavioural
The bimanual arm trainer (BAT) is a device that involves hardware that interfaces with a computer game. The BAT promotes shoulder external rotation and elbow extension in the paretic arm by coupling movements of the paretic arm with the less affected limb as the participant matches his/her arm movements to those of a virtual avatar. The less-affected side and paretic limb are placed in the BAT apparatus and the less affected limb "drives" the impaired limb through passive, symmetrical movements that simulate rowing down a virtual river. The protocol created by the investigators group, leads the patient through an active-passive training progression similar to paradigms used in neural priming studies. Through these series of movements, the goal is to restore balance between the muscles of the upper back and chest to maximize range of motion in preparation for improved quality of movement.
| Study group | Role | What they receive |
|---|---|---|
| Video Gaming Technology (VGT) based arm training | Experimental | Patients who meet inclusion criteria will be assessed for level of arm impairment and allocated to either MindPod VGT or Bimanual Arm Trainer VGT based on the severity of impairment. Patients will complete up to 60 minutes of VGT treatment in addition to the standard of care therapy (Physical, occupational, and or speech therapy). Patients will be monitored before, during, and after the sessions for tolerance and response to the treatment. This will include physiological response using measures such as blood pressure, heart rate, and pulse oximeter. Self reported pain and fatigue will be collected using visual analog scales. Safety issues that are predefined as line dislodgement, falls, change in vital signs or pain necessitating interruption of the therapy session will be measured and calculated as the number of adverse events as a proportion of the number of sessions attended Receives: Behavioral: MindPod Dolphin VGT; Behavioral: Bimanual Arm Trainer VGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Adherence to the protocol as assessed by session attendance
Adherence to the protocol will be calculated by determining the number of sessions attended as a proportion of the number of possible sessions.
Measured: Immediately Post Intervention
Feasibility: Efficiency (total time on task)
Efficiency will be calculated by examining the amount of practice (Total time on task) as a proportion of total minutes (Total protocol target duration).
Measured: Immediately Post Intervention
Feasibility: Acceptability of the intervention as assessed by the Technology Acceptance Measure
Technology Acceptance Measure; scale range is 1-7 (Strongly disagree to Strongly agree) and higher scores indicate better acceptability.
Measured: Post intervention up to 2 weeks
Feasibility: Acceptability of the intervention as assessed by the Intrinsic Motivation Inventory
Acceptability of the intervention will be gathered using the Intrinsic Motivation Inventory. This is a 19-item inventory using a 1-7 scale (not at all true to very true) with 3 sub scales: Interest/Enjoyment, Value/Usefulness, Effort/Importance. Higher scores indicate high acceptability.
Measured: Post Intervention up to 2 weeks
Heart rate
Heart rate; mean number of beats per minute.
Measured: Baseline, Immediately Post-Intervention
Blood pressure (mmHg)
Systolic and diastolic blood pressure.
Measured: Baseline, Immediately Post-Intervention
Pain as assessed by Wong-Baker Faces Pain Rating Scale
Pain score; (0-10) 10 indicates high level of pain
Measured: Baseline, Immediately Post-Intervention
Fatigue as assessed by Fatigue Visual Analog Scale
Fatigue score; 0-10 with 10 being greater levels of fatigue
Measured: Baseline, Immediately Post-Intervention
Safety as assessed by the number of adverse events
Safety as assessed by the number of adverse events.
Measured: Baseline, Immediately Post-Intervention
Secondary outcomes (2)
Efficacy: Fugl Meyer Upper Extremity
66-point scale that looks at change in arm and hand function at the impairment level as assessed by the Fugl Meyer Upper Extremity Assessment of motor control (FM-UE). The FM-UE uses a 3-point ordinal scale to evaluate sensorimotor function of the arm and hand of the affected upper extremity during reach and grasp movements in and out of synergistic movement patterns. Total scores of 66 are equal to normal movement or no impairment.
Measured: Baseline, Immediately Post-Intervention
Efficacy: Gross Grasp (Dynamometry)
Change in gross grasp will be captured using dynamometry measured in pounds of force output. Three measures will be taken on the right and left hand and the value will be averaged using a calibrated dynamometer and standardized testing procedure. Greater force output is equal to greater grip strength.
Measured: Baseline, Immediately Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start12 Mar 2020
- Primary completion12 Mar 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Bahouth, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691880
- Sponsor's protocol ID
- IRB00204731
- Acronym
- SMARTER
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.
PubMed 12234086Prabhakaran S, Zarahn E, Riley C, Speizer A, Chong JY, Lazar RM, Marshall RS, Krakauer JW. Inter-individual variability in the capacity for motor recovery after ischemic stroke. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):64-71. doi: 10.1177/1545968307305302. Epub 2007 Aug 8.
PubMed 17687024Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.
PubMed 24136129Zeiler SR, Hubbard R, Gibson EM, Zheng T, Ng K, O'Brien R, Krakauer JW. Paradoxical Motor Recovery From a First Stroke After Induction of a Second Stroke: Reopening a Postischemic Sensitive Period. Neurorehabil Neural Repair. 2016 Sep;30(8):794-800. doi: 10.1177/1545968315624783. Epub 2015 Dec 31.
PubMed 26721868Stanmore E, Stubbs B, Vancampfort D, de Bruin ED, Firth J. The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials. Neurosci Biobehav Rev. 2017 Jul;78:34-43. doi: 10.1016/j.neubiorev.2017.04.011. Epub 2017 Apr 23.
PubMed 28442405Gagnon MP, Orruno E, Asua J, Abdeljelil AB, Emparanza J. Using a modified technology acceptance model to evaluate healthcare professionals' adoption of a new telemonitoring system. Telemed J E Health. 2012 Jan-Feb;18(1):54-9. doi: 10.1089/tmj.2011.0066. Epub 2011 Nov 14.
PubMed 22082108Aminov A, Rogers JM, Middleton S, Caeyenberghs K, Wilson PH. What do randomized controlled trials say about virtual rehabilitation in stroke? A systematic literature review and meta-analysis of upper-limb and cognitive outcomes. J Neuroeng Rehabil. 2018 Mar 27;15(1):29. doi: 10.1186/s12984-018-0370-2.
PubMed 29587853Hayward KS, Brauer SG. Dose of arm activity training during acute and subacute rehabilitation post stroke: a systematic review of the literature. Clin Rehabil. 2015 Dec;29(12):1234-43. doi: 10.1177/0269215514565395. Epub 2015 Jan 7.
PubMed 25568073Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
PubMed 22179294
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating SMARTS 2: the Integration of Video Gaming Technology Into Traditional Rehabilitation
- ClinicalTrials.gov ID
- NCT06691880
- Acronym / sponsor ID
- SMARTER / IRB00204731
- Conditions
- Subacute Stroke, Acute Stroke
- Keywords
- stroke, brain repair, recovery, video gaming, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 18 Nov 2024 (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 investigators are investigating ways to incorporate new technologies that can enhance functional outcome after neurological insult into the patient recovery space. In order to accelerate the translation of these technologies to patient care spaces, the investigators need to identify the locations that are feasible for its use. Currently the investigators are using video game technologies that are used to maximize motor recovery of impaired upper extremities after neurological insult in the outpatient (clinic) setting. These technologies interface with robotics and other hardware to create a therapy experience that is fun, engaging, dynamic, challenging, and promotes repetitions that are otherwise difficult to achieve during conventional post-stroke rehabilitation. The investigators think early use of these technologies could enhance recovery of the arm, but It is not known if use of these technologies in the early post-stroke recovery period is safe and feasible.
Detailed description
This study explores a protocolized approach to high-dosed, video-game-based arm training in addition to standard of care rehabilitation in the acute/sub-acute phase of stroke recovery. Patients admitted to the Johns Hopkins Hospital rehabilitation unit or the Brain Rescue Unit with new unilateral upper limb weakness as a result of the patient's sequela will be considered for enrollment. Once consented, participants will be seen 4-5 days per week for up to 60 minutes of additional arm training using gaming technology. Participant response to training will be measured before and after the intervention and function and impairment level will be measured pre and post the training protocol. Participants will be expected to participate in the training protocol for the duration of the hospital stay.
The study involves patients who were already hospitalized at a large teaching institution in Maryland. Participants were screened for eligibility on admission to the hospital. If eligible, the patient was screened in person to determine if he/she was able to follow a 1 step functional command and for willingness to participate. Once agreeable, patients and/or the patient's surrogate decision makers were consented to enroll into the study. Patients were included if a stroke was confirmed by CT or MRI with subsequent unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in Manual Muscle Testing (MMT) score from unaffected side to affected side). Patients were excluded if unable to sit upright for at least 5 minutes in a chair without arm support, unable to follow 1 step functional commands or had a vision impairment that impeded seeing the television screen. Patients were also excluded if the patient had medical instability as defined by the care provider, orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity, heart conditions that limits participation in exercise, active seizures or epilepsy or the inability to communicate pain status.
Once consented, baseline assessments are administered and include the FM-UE and dynamometry. The patients are stratified to a gaming technology based on the baseline FM-UE score. Patients with a FM-UE less than 25 are placed in the Bimanual Arm Training group. During the treatment session, the patients are monitored for tolerance of the session using pre and post vitals including Blood Pressure, Heart Rate, and pulse oximetry. Pre/post pain and fatigue ratings are also maintained using a 10 point-likert scale. Trained clinicians gathered session start and end time. Technological difficulties and other interruptions are documented. Adverse events are gathered and include any swelling or bruising, cut/scratch/irritations, and new numbness or tingling. Intervention clinicians use a detailed stopping criteria to monitor the patient for tolerance and participation in the target time on task. The subjects receive intervention daily outside of the subject's regularly scheduled therapy for the 4-5 days a week (pending clinician availability) for the length of the hospital stay.
On the day of or day prior to discharge, FM-UE and dynamometry is gathered again. Qualitative post-intervention outcome measures are gathered for and included a survey of the patient's experience using a Likert-Scale based questionnaire, a Technology Acceptance Model survey (examines the patient's experience using technology and breaks it down into previously defined domains: Perceived Ease of Use (PEU), Perceived Usefulness (PU), Attitude Toward Using (ATU), Behavioral Intention to Use (BIU), and the Intrinsic Motivation Inventory (IMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video Gaming Technology (VGT) based arm training | Experimental | Behavioral: MindPod Dolphin VGT, Behavioral: Bimanual Arm Trainer VGTPatients who meet inclusion criteria will be assessed for level of arm impairment and allocated to either MindPod VGT or Bimanual Arm Trainer VGT based on the severity of impairment. Patients will complete up to 60 minutes of VGT treatment in addition to the standard of care therapy (Physical, occupational, and or speech therapy). Patients will be monitored before, during, and after the sessions for tolerance and response to the treatment. This will include physiological response using measures such as blood pressure, heart rate, and pulse oximeter. Self reported pain and fatigue will be collected using visual analog scales. Safety issues that are predefined as line dislodgement, falls, change in vital signs or pain necessitating interruption of the therapy session will be measured and calculated as the number of adverse events as a proportion of the number of sessions attended |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to Meyer 7 inpatient rehabilitation unit (CIIRP) or Zayed 12 West (12W) Brain Rescue Unit (BRU)
- Unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in MMT score from unaffected side to affected side)
Key exclusion criteria (8 listed)
- Unable to sit upright for at least 3 minutes
- Unable to follow 1 step commands
- Vision impairment that impedes seeing the television screen
- Medical instability as defined by the care provider
- Orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity
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 |
|---|---|---|
| MindPod Dolphin VGTThe MindPod Dolphin, is an interactive video game that allows users to engage in "non-task-based tasks" to motivate the users to play and relearn motor skills. The MindPod gaming platform uses markerless tracking to sense the patient's affected arm. The paretic limb controls Bandit the dolphin underwater in an effort to eat fish. The patient learns to map his/her movements to Bandit in a 3-Dimensional work space to reach the targets. During gaming, the therapist titrates game difficulty. Bilateral gaming components are used (the participant uses a controller with the participant's less-affected limb to control the timing of Bandit's movement) and in-game difficulty can be adjusted to create an immersive, challenging, and engaging experience. In order to be successful, the patient must coordinate both arms to control the temporal and spatial aspects of the game. | Behavioural | Video Gaming Technology (VGT) based arm training |
| Bimanual Arm Trainer VGTThe bimanual arm trainer (BAT) is a device that involves hardware that interfaces with a computer game. The BAT promotes shoulder external rotation and elbow extension in the paretic arm by coupling movements of the paretic arm with the less affected limb as the participant matches his/her arm movements to those of a virtual avatar. The less-affected side and paretic limb are placed in the BAT apparatus and the less affected limb "drives" the impaired limb through passive, symmetrical movements that simulate rowing down a virtual river. The protocol created by the investigators group, leads the patient through an active-passive training progression similar to paradigms used in neural priming studies. Through these series of movements, the goal is to restore balance between the muscles of the upper back and chest to maximize range of motion in preparation for improved quality of movement. | Behavioural | Video Gaming Technology (VGT) based arm training |
Primary outcome
Feasibility: Adherence to the protocol as assessed by session attendance
Time frame: Immediately Post Intervention
Adherence to the protocol will be calculated by determining the number of sessions attended as a proportion of the number of possible sessions.
Feasibility: Efficiency (total time on task)
Time frame: Immediately Post Intervention
Efficiency will be calculated by examining the amount of practice (Total time on task) as a proportion of total minutes (Total protocol target duration).
Feasibility: Acceptability of the intervention as assessed by the Technology Acceptance Measure
Time frame: Post intervention up to 2 weeks
Technology Acceptance Measure; scale range is 1-7 (Strongly disagree to Strongly agree) and higher scores indicate better acceptability.
Feasibility: Acceptability of the intervention as assessed by the Intrinsic Motivation Inventory
Time frame: Post Intervention up to 2 weeks
Acceptability of the intervention will be gathered using the Intrinsic Motivation Inventory. This is a 19-item inventory using a 1-7 scale (not at all true to very true) with 3 sub scales: Interest/Enjoyment, Value/Usefulness, Effort/Importance. Higher scores indicate high acceptability.
Heart rate
Time frame: Baseline, Immediately Post-Intervention
Heart rate; mean number of beats per minute.
Blood pressure (mmHg)
Time frame: Baseline, Immediately Post-Intervention
Systolic and diastolic blood pressure.
Pain as assessed by Wong-Baker Faces Pain Rating Scale
Time frame: Baseline, Immediately Post-Intervention
Pain score; (0-10) 10 indicates high level of pain
Fatigue as assessed by Fatigue Visual Analog Scale
Time frame: Baseline, Immediately Post-Intervention
Fatigue score; 0-10 with 10 being greater levels of fatigue
Safety as assessed by the number of adverse events
Time frame: Baseline, Immediately Post-Intervention
Safety as assessed by the number of adverse events.
2 secondary outcomes
Efficacy: Fugl Meyer Upper Extremity
Time frame: Baseline, Immediately Post-Intervention
Efficacy: Gross Grasp (Dynamometry)
Time frame: Baseline, Immediately Post-Intervention
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 16 Mar 2026.
- Background: PubMed 12234086Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.
- Background: PubMed 17687024Prabhakaran S, Zarahn E, Riley C, Speizer A, Chong JY, Lazar RM, Marshall RS, Krakauer JW. Inter-individual variability in the capacity for motor recovery after ischemic stroke. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):64-71. doi: 10.1177/1545968307305302. Epub 2007 Aug 8.
- Background: PubMed 24136129Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.
- Background: PubMed 26721868Zeiler SR, Hubbard R, Gibson EM, Zheng T, Ng K, O'Brien R, Krakauer JW. Paradoxical Motor Recovery From a First Stroke After Induction of a Second Stroke: Reopening a Postischemic Sensitive Period. Neurorehabil Neural Repair. 2016 Sep;30(8):794-800. doi: 10.1177/1545968315624783. Epub 2015 Dec 31.
- Background: PubMed 28442405Stanmore E, Stubbs B, Vancampfort D, de Bruin ED, Firth J. The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials. Neurosci Biobehav Rev. 2017 Jul;78:34-43. doi: 10.1016/j.neubiorev.2017.04.011. Epub 2017 Apr 23.
- Background: PubMed 22082108Gagnon MP, Orruno E, Asua J, Abdeljelil AB, Emparanza J. Using a modified technology acceptance model to evaluate healthcare professionals' adoption of a new telemonitoring system. Telemed J E Health. 2012 Jan-Feb;18(1):54-9. doi: 10.1089/tmj.2011.0066. Epub 2011 Nov 14.
- Background: PubMed 29587853Aminov A, Rogers JM, Middleton S, Caeyenberghs K, Wilson PH. What do randomized controlled trials say about virtual rehabilitation in stroke? A systematic literature review and meta-analysis of upper-limb and cognitive outcomes. J Neuroeng Rehabil. 2018 Mar 27;15(1):29. doi: 10.1186/s12984-018-0370-2.
- Background: PubMed 25568073Hayward KS, Brauer SG. Dose of arm activity training during acute and subacute rehabilitation post stroke: a systematic review of the literature. Clin Rehabil. 2015 Dec;29(12):1234-43. doi: 10.1177/0269215514565395. Epub 2015 Jan 7.
- Background: PubMed 22179294Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
- 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.
Mona Bahouth, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindPod Dolphin VGT and Bimanual Arm Trainer VGT in people with Subacute Stroke and Acute Stroke, run by Johns Hopkins University 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 2 inclusion and 8 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 16 Mar 2026. 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?
Feasibility: Adherence to the protocol as assessed by session attendance (time frame: Immediately Post Intervention). The study lists 9 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 NCT06691880, which also lists 9 linked publications.
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 16 Mar 2026.