Stroke, AcutevREHABNCT03741400
Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke
A study testing Neofect RAPAEL Smart Glove in people with Stroke, Acute and Cerebral Infarction, run by Stanford University at 4 sites in 2 countries.
Trial summary
The Virtual Reality Glove for Hand and Arm Rehabilitation (vREHAB) trial is a randomized, controlled, phase 3 trial aiming to evaluate the safety, usability, and efficacy of a virtual reality biofeedback system (Neofect RAPAEL Smart Glove) to promote recovery of distal arm and hand function in the acute and subacute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Cerebral Infarction
- What is being tested?
- Neofect RAPAEL Smart Glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2018to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of ischemic or hemorrhagic stroke prior to enrollment.
- unilateral hand/arm weakness from stroke with indication for upper limb rehabilitation therapy.
- ability to successfully play 2 out 4 pre-selected test games with the Smart Glove. The test specific games and criteria for passing are as follows:
- Pour the wine (Pronation/Supination): make 5 pours in first 1 minute
- Snow Ball Fight (Wrist Flexion/Extension w/ gravity eliminated): take down 3 objects in first 1 minute
- Scrub the Floor (Wrist Radial/Ulnar deviation w/ gravity eliminated): scrub the floor 5 times in first 1 minute
- Float the Fish (Finger Flexion/Extension): make 50 meters with 3 or less bumps in first 3 minutes
Who cannot join
- Age <18 years
- history of visually provoked seizures
- psychological disorder that could impede participation
- pre-existing neurologic disorder which causes significant deficits in arm/hand function (e.g. Parkinson's disease, peripheral neuropathy, etc.)
- severe receptive aphasia which results in inability to participate with the Smart Glove.
- cognitive impairment which results in inability to participate with the Smart Glove.
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- severe pain impeding upper extremity rehabilitation and use of the Smart Glove
- limited life-expectancy which makes it unlikely that patient will be able to complete the 24-week follow-up visit
- any medical or other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Stanford University
Palo Alto, California, 94305
Intermountain Healthcare
Salt Lake City, Utah, 84103
Santa Clara Valley Medical Center
San Jose, California, 95128
About this study
The Virtual Reality Glove for Hand and Arm Rehabilitation (vREHAB) trial is a randomized, controlled, phase 3 trial aiming to evaluate the safety, usability, and efficacy of a virtual reality biofeedback system (Neofect RAPAEL Smart Glove) to promote recovery of distal arm and hand function in the acute and subacute period after stroke, as compared to standard of care therapy. The aims of the study is to demonstrate:
- the effect of Smart Glove use on functional recovery, in addition to standard of care rehabilitation therapy.
- the feasibility of increasing the dose of rehabilitation in acute stroke patients with the Smart Glove.
- the effect of Smart Glove use on quality of life.
Read the detailed description
The Neofect Smart Glove is a commercially available, non-invasive biofeedback based system for distal upper extremity rehabilitation. The Smart Glove is very lightweight and allows for easy movement of all distal upper extremity joints. It consists of a glove-shaped sensor device and a software application which can be used with either a large screen or a portable tablet. The system includes multiple Activities of Daily Living (ADL)-based training games, and the system tracks the motion and posture of the wearer's distal limb as they participate. Games can be selected to focus on certain movements (such as forearm pronation/supination, wrist flexion/extension, finger flexion/extension, etc.) based on the needs of the wearer. The software includes a smart learning algorithm, in which the computer automatically adjusts to the optimal level of difficulty to balance challenge and motivation. After initial set-up, the device requires no therapist supervision to use.
Patients will be eligible for the study if they have had an ischemic or hemorrhagic stroke and (2) have impaired arm/hand function secondary to the stroke (see below for specific inclusion and exclusion criteria). We will recruit eligible patients from acute care hospitals, acute rehabilitation units, and outpatient facilities. Enrolled patients will be randomized (1:1 ratio) to standard rehabilitation therapy versus standard rehabilitation therapy plus Smart Glove use. All patients will be allowed to participate in any scheduled outpatient rehabilitation during the study.
The study consists of a 12-week intervention period and a 12-week follow-up period. During the 12-week intervention period all patients will receive their usual rehabilitation therapy, with their therapists documenting rehabilitation dose in a journal provided at the start of the study. In addition, subjects randomized to the Smart Glove therapy arm will be provided with a Smart Glove system, which includes the glove and tablet. Subjects will be instructed to use the system for at least one session per day for 5 days per week during the 12-week intervention period. Participants will present for in-person visits on weeks 6, 12, and 24 for blinded assessments by study coordinators. At the completion of the intervention period, subjects will return the Smart Glove and subjects in both arms of the study will only receive usual care during the 12-week follow-up period. Subjects will have a final assessment at week 24 (12 weeks after completing the intervention) to assess for persistence of effect.
All efficacy analyses are analyzed under the intention to treat principle. The primary efficacy outcome is the change in score on the Jebsen Taylor Hand Test between baseline and week 12. Secondary efficacy endpoints are changes in scores on the upper extremity Fugl-Meyer Scale, Stroke Impact Scale, and total dose of rehabilitation received during the 24-week intervention period. Persistence of the treatment effect will be tested by comparing changes in scores on the Jebsen Taylor Hand Test and Fugl-Meyer upper extremity score at 24 weeks between treatment groups
- Conditions
- Stroke, Acute, Cerebral Infarction
- Being tested
- Neofect RAPAEL Smart Glove
- Keywords
- motor weakness, rehabilitation
- Medical subject headings
- Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neofect RAPAEL Smart GloveDevice
The Neofect Rapael Smart Glove is a biofeedback system designed for upper extremity rehabilitation in stroke survivors. It includes a glove-shaped sensor device and a software application.
| Study group | Role | What they receive |
|---|---|---|
| Standard Occupational Therapy + Smart Glove | Experimental | Subjects randomized to this arm will be expected to use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy. Receives: Device: Neofect RAPAEL Smart Glove |
| Standard Occupational Therapy | No intervention | Subjects in the control arm will undergo standard of care occupational therapy as prescribed by their care team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Impairment, Jebsen Taylor Hand Function Test
The change in scores on the Jebsen-Taylor hand function test (JTHFT) from baseline to twelve weeks (in seconds) was compared between treatment groups.
The JTHFT is a standardized and objective measure of hand functions commonly used in activities of daily living (ADLs). The test consists of seven subtests separated into fine (JTHFT-Fine) and gross (JTHFT-Gross) motor tasks. Fine motor tasks include writing, simulated page turning, lifting small objects, and simulated feeding. Gross motor tasks include stacking checkers, lifting large light objects, and lifting large heavy objects. The score was calculated as the total number of seconds to perform the tasks, with a lower score indicating better function. Patients who could not complete a task within 90 seconds were assigned a maximum score of 90 seconds for that task. Therefore, the maximum score was 360 sec for the JTHFT-Fine, 270 sec for the JTHFT-Gross, and 630 sec for the JTHFT-Total.
Measured: baseline, 12 weeks
Secondary outcomes (5)
Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment
The change in scores on the Upper Extremity Fugl-Meyer [0-66, with higher score meaning better motor function] test from baseline to twelve weeks will be compared between treatment groups. The test measures reflex activity, selective movement, and coordination of the hand, wrist, forearm, elbow, and shoulder.
Measured: baseline, 12 weeks
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
The change in scores on the Jebsen-Taylor hand function test from baseline to twenty-four weeks (in seconds) was compared between treatment groups.
The JTHFT is a standardized and objective measure of hand functions commonly used in activities of daily living (ADLs). The test consists of seven subtests separated into fine (JTHFT-Fine) and gross (JTHFT-Gross) motor tasks. Fine motor tasks include writing, simulated page turning, lifting small objects, and simulated feeding. Gross motor tasks include stacking checkers, lifting large light objects, and lifting large heavy objects. The score was calculated as the total number of seconds to perform the tasks, with a lower score indicating better function. Patients who could not complete a task within 90 seconds were assigned a maximum score of 90 seconds for that task. Therefore, the maximum score was 360 sec for the JTHFT-Fine, 270 sec for the JTHFT-Gross, and 630 sec for the JTHFT-Total.
Measured: baseline, 24 weeks
Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test
Change in scores in Upper Extremity Fugl-Meyer [0-66, with higher score meaning better motor function] test between baseline and 24 weeks will be compared between treatment groups. The test measures reflex activity, selective movement, and coordination of the hand, wrist, forearm, elbow, and shoulder.
Measured: baseline, 24 weeks
Total Dose of Upper Extremity Rehabilitation
Total dose (minutes) of all upper extremity rehabilitation therapy, including Smart Glove therapy, received during the 12-week intervention period will be compared between treatment groups.
Measured: 12 weeks
Self-rated Stroke-related Disability Between Each Treatment Group
Domain scores (0-100, with 100 being better self-rated function in each of: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation) on the Stroke Impact Scale will be compared between treatment groups at 12 weeks and at 24 weeks.
Measured: Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Oct 2018
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- NEOFECT Rehabilitation Solutions
- Responsible party
- Principal investigator, Maarten Lansberg, Stanford University
- Investigators
- Maarten G Lansberg, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741400
- Sponsor's protocol ID
- 46423
- Acronym
- vREHAB
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2018
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT03741400
- Acronym / sponsor ID
- vREHAB / 46423
- Conditions
- Stroke, Acute, Cerebral Infarction
- Keywords
- motor weakness, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- NEOFECT Rehabilitation Solutions
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Virtual Reality Glove for Hand and Arm Rehabilitation (vREHAB) trial is a randomized, controlled, phase 3 trial aiming to evaluate the safety, usability, and efficacy of a virtual reality biofeedback system (Neofect RAPAEL Smart Glove) to promote recovery of distal arm and hand function in the acute and subacute period after stroke, as compared to standard of care therapy. The aims of the study is to demonstrate:
- the effect of Smart Glove use on functional recovery, in addition to standard of care rehabilitation therapy.
- the feasibility of increasing the dose of rehabilitation in acute stroke patients with the Smart Glove.
- the effect of Smart Glove use on quality of life.
Detailed description
The Neofect Smart Glove is a commercially available, non-invasive biofeedback based system for distal upper extremity rehabilitation. The Smart Glove is very lightweight and allows for easy movement of all distal upper extremity joints. It consists of a glove-shaped sensor device and a software application which can be used with either a large screen or a portable tablet. The system includes multiple Activities of Daily Living (ADL)-based training games, and the system tracks the motion and posture of the wearer's distal limb as they participate. Games can be selected to focus on certain movements (such as forearm pronation/supination, wrist flexion/extension, finger flexion/extension, etc.) based on the needs of the wearer. The software includes a smart learning algorithm, in which the computer automatically adjusts to the optimal level of difficulty to balance challenge and motivation. After initial set-up, the device requires no therapist supervision to use.
Patients will be eligible for the study if they have had an ischemic or hemorrhagic stroke and (2) have impaired arm/hand function secondary to the stroke (see below for specific inclusion and exclusion criteria). We will recruit eligible patients from acute care hospitals, acute rehabilitation units, and outpatient facilities. Enrolled patients will be randomized (1:1 ratio) to standard rehabilitation therapy versus standard rehabilitation therapy plus Smart Glove use. All patients will be allowed to participate in any scheduled outpatient rehabilitation during the study.
The study consists of a 12-week intervention period and a 12-week follow-up period. During the 12-week intervention period all patients will receive their usual rehabilitation therapy, with their therapists documenting rehabilitation dose in a journal provided at the start of the study. In addition, subjects randomized to the Smart Glove therapy arm will be provided with a Smart Glove system, which includes the glove and tablet. Subjects will be instructed to use the system for at least one session per day for 5 days per week during the 12-week intervention period. Participants will present for in-person visits on weeks 6, 12, and 24 for blinded assessments by study coordinators. At the completion of the intervention period, subjects will return the Smart Glove and subjects in both arms of the study will only receive usual care during the 12-week follow-up period. Subjects will have a final assessment at week 24 (12 weeks after completing the intervention) to assess for persistence of effect.
All efficacy analyses are analyzed under the intention to treat principle. The primary efficacy outcome is the change in score on the Jebsen Taylor Hand Test between baseline and week 12. Secondary efficacy endpoints are changes in scores on the upper extremity Fugl-Meyer Scale, Stroke Impact Scale, and total dose of rehabilitation received during the 24-week intervention period. Persistence of the treatment effect will be tested by comparing changes in scores on the Jebsen Taylor Hand Test and Fugl-Meyer upper extremity score at 24 weeks between treatment groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Occupational Therapy + Smart Glove | Experimental | Device: Neofect RAPAEL Smart GloveSubjects randomized to this arm will be expected to use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy. |
| Standard Occupational Therapy | No intervention | –Subjects in the control arm will undergo standard of care occupational therapy as prescribed by their care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a diagnosis of ischemic or hemorrhagic stroke prior to enrollment.
- unilateral hand/arm weakness from stroke with indication for upper limb rehabilitation therapy.
- ability to successfully play 2 out 4 pre-selected test games with the Smart Glove. The test specific games and criteria for passing are as follows:
Key exclusion criteria (9 listed)
- Age <18 years
- history of visually provoked seizures
- psychological disorder that could impede participation
- pre-existing neurologic disorder which causes significant deficits in arm/hand function (e.g. Parkinson's disease, peripheral neuropathy, etc.)
- severe receptive aphasia which results in inability to participate with the Smart Glove.
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 |
|---|---|---|
| Neofect RAPAEL Smart GloveThe Neofect Rapael Smart Glove is a biofeedback system designed for upper extremity rehabilitation in stroke survivors. It includes a glove-shaped sensor device and a software application. | Device | Standard Occupational Therapy + Smart Glove |
Primary outcome
Change in Functional Impairment, Jebsen Taylor Hand Function Test
Time frame: baseline, 12 weeks
The change in scores on the Jebsen-Taylor hand function test (JTHFT) from baseline to twelve weeks (in seconds) was compared between treatment groups. The JTHFT is a standardized and objective measure of hand functions commonly used in activities of daily living (ADLs). The test consists of seven subtests separated into fine (JTHFT-Fine) and gross (JTHFT-Gross) motor tasks. Fine motor tasks include writing, simulated page turning, lifting small objects, and simulated feeding. Gross motor tasks include stacking checkers, lifting large light objects, and lifting large heavy objects. The score was calculated as the total number of seconds to perform the tasks, with a lower score indicating better function. Patients who could not complete a task within 90 seconds were assigned a maximum score of 90 seconds for that task. Therefore, the maximum score was 360 sec for the JTHFT-Fine, 270 sec for the JTHFT-Gross, and 630 sec for the JTHFT-Total.
5 secondary outcomes
Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment
Time frame: baseline, 12 weeks
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
Time frame: baseline, 24 weeks
Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test
Time frame: baseline, 24 weeks
Total Dose of Upper Extremity Rehabilitation
Time frame: 12 weeks
Self-rated Stroke-related Disability Between Each Treatment Group
Time frame: Weeks 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maarten G Lansberg, MD principal investigator
Stanford University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neofect RAPAEL Smart Glove in people with Stroke, Acute and Cerebral Infarction, run by Stanford University at 4 sites in 2 countries.
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 7 inclusion and 9 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Functional Impairment, Jebsen Taylor Hand Function Test (time frame: baseline, 12 weeks). 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 9 Oct 2024.