Cerebral Infarction, Stroke, Acute
Conditions
Keywords
motor weakness, rehabilitation
Brief 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 period after stroke, as compared to standard of care therapy. The aims of the study is to demonstrate: 1. the effect of Smart Glove use on functional recovery, in addition to standard of care rehabilitation therapy. 2. the feasibility of increasing the dose of rehabilitation in acute stroke patients with the Smart Glove. 3. 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
Interventions
DEVICENeofect RAPAEL Smart Glove
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.
Sponsors
NEOFECT Rehabilitation Solutions
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessor that will be performing the interval assessments will be blinded to treatment arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Impairment, Jebsen Taylor Hand Function Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment | baseline, 12 weeks | 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. |
| Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | baseline, 24 weeks | 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. |
| Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test | baseline, 24 weeks | 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. |
| Total Dose of Upper Extremity Rehabilitation | 12 weeks | 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. |
| Self-rated Stroke-related Disability Between Each Treatment Group | Weeks 12 and 24 | 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. |
Countries
Belgium, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Occupational Therapy Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team. | 24 |
| Standard Occupational Therapy + Smart Glove Participants randomized to this arm 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. | 18 |
| Total | 42 |
Baseline characteristics
| Characteristic | Standard Occupational Therapy + Smart Glove | Total | Standard Occupational Therapy |
|---|---|---|---|
| Age, Continuous | 59 years | 60 years | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 35 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 27 Participants | 16 Participants |
| Region of Enrollment Belgium | 6 Participants | 14 Participants | 8 Participants |
| Region of Enrollment United States | 12 Participants | 28 Participants | 16 Participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Male | 11 Participants | 28 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 1 / 30 |
| other Total, other adverse events | 7 / 30 | 9 / 30 |
| serious Total, serious adverse events | 0 / 30 | 1 / 30 |
Outcome results
Primary
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.
Time frame: baseline, 12 weeks
Population: Participants who completed the protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Occupational Therapy | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Baseline-Total | 119 seconds |
| Standard Occupational Therapy | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Change at week 12-Total | -69 seconds |
| Standard Occupational Therapy | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Baseline-Fine | 87 seconds |
| Standard Occupational Therapy | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Change at week 12-Fine | -37 seconds |
| Standard Occupational Therapy | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Baseline-Gross | 30 seconds |
| Standard Occupational Therapy | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Change at week 12-Gross | -23 seconds |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Baseline-Gross | 59 seconds |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Baseline-Total | 181 seconds |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Change at week 12-Fine | -35 seconds |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Change at week 12-Total | -64 seconds |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Change at week 12-Gross | -31 seconds |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Jebsen Taylor Hand Function Test | Baseline-Fine | 131 seconds |
Comparison: Analysis of change in total secondsp-value: 0.88ANCOVA
Comparison: Analysis of change in fine motor skill assessmentp-value: 0.99ANCOVA
Comparison: Analysis of change in gross motor skills assessmentp-value: 0.8ANCOVA
Secondary
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.
Time frame: baseline, 12 weeks
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Occupational Therapy | Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment | Baseline | 55 score on a scale |
| Standard Occupational Therapy | Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment | Change at week 12 | 8 score on a scale |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment | Baseline | 46 score on a scale |
| Standard Occupational Therapy + Smart Glove | Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment | Change at week 12 | 8 score on a scale |
p-value: 0.61ANCOVA
Secondary
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.
Time frame: baseline, 24 weeks
Population: Participants who completed the protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Baseline-Total | 119 seconds |
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Change at week 24-Total | -47 seconds |
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Baseline-Fine | 87 seconds |
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Change at week 24-Fine | -37 seconds |
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Baseline-Gross Baseline-Gross | 30 seconds |
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Change at week 24-Gross | -16 seconds |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Baseline-Gross Baseline-Gross | 59 seconds |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Baseline-Total | 181 seconds |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Change at week 24-Fine | -35 seconds |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Change at week 24-Total | -82 seconds |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Change at week 24-Gross | -33 seconds |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test | Baseline-Fine | 131 seconds |
Comparison: Analysis of change in gross motor skills assessmentp-value: 0.38ANCOVA
Comparison: Analysis of change in total secondsp-value: 0.47ANCOVA
Comparison: Analysis of change in fine motor skill assessmentp-value: 0.55ANCOVA
Secondary
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.
Time frame: baseline, 24 weeks
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test | Baseline | 55 score on a scale |
| Standard Occupational Therapy | Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test | Change at week 24 | 7 score on a scale |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test | Baseline | 46 score on a scale |
| Standard Occupational Therapy + Smart Glove | Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test | Change at week 24 | 11 score on a scale |
p-value: 0.24ANCOVA
Secondary
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.
Time frame: Weeks 12 and 24
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Occupational Therapy | Self-rated Stroke-related Disability Between Each Treatment Group | Week 12 | 63 score on a scale |
| Standard Occupational Therapy | Self-rated Stroke-related Disability Between Each Treatment Group | Week 24 | 75 score on a scale |
| Standard Occupational Therapy + Smart Glove | Self-rated Stroke-related Disability Between Each Treatment Group | Week 12 | 65 score on a scale |
| Standard Occupational Therapy + Smart Glove | Self-rated Stroke-related Disability Between Each Treatment Group | Week 24 | 82.5 score on a scale |
Comparison: Analysis at week 12p-value: 0.926ANCOVA
Comparison: Analysis at week 24p-value: 0.828ANCOVA
Secondary
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.
Time frame: 12 weeks
Population: Participants who completed the protocol and with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Occupational Therapy | Total Dose of Upper Extremity Rehabilitation | 584 minutes |
| Standard Occupational Therapy + Smart Glove | Total Dose of Upper Extremity Rehabilitation | 1434 minutes |
p-value: 0.18Mann-Whitney U test