Stroke
Conditions
Brief summary
Regaining upper extremity function is very important for stroke survivors to increase their independence and ability to perform activities of daily living (ADLs). Outpatient stroke rehabilitation currently takes place in a therapy clinic, however access can be limited by financial resources and transportation difficulties. The Feasibility of Home-Based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke Study seeks to explore the safety, usability, and efficacy of a home based virtual reality biofeedback system to promote distal upper extremity (wrist and hand) recovery after stroke. The purpose of the study is to assess the feasibility of using a home-based virtual reality system to increase the dose of upper extremity rehabilitation in subacute and chronic stroke patients.
Detailed description
In this pilot study, we propose to test a virtual reality home-based intervention as an alternative or supplement to traditional rehabilitation for upper extremity weakness after stroke. We are hoping to discover that the device is easily adopted by patients and increases the dose of rehabilitation, as well as potentially leads to motor recovery. With the increasing affordability and accessibility of virtual reality (VR) systems, VR has emerged as a new platform for stroke rehabilitation. VR therapy involves using computer-based programs to simulate daily tasks and events. VR has shown promise in both allowing patients to practice activities that directly translate to their ADLs, as well as motivating them by providing a novel and interesting virtual environment. Relevance Regaining upper extremity function is very important for stroke survivors to increase their independence and ability to perform ADLs. The large majority of outpatient stroke rehabilitation currently takes place in a therapy clinic, however access is often limited by resource allocation, financial hardship, and transportation difficulties. The Smart Glove can provide an inexpensive and convenient means for stroke patients to continue their rehabilitation in the comfort of their own home. Patient Population Subacute and chronic stroke patients presenting with upper extremity weakness, as identified by Stanford physicians in clinic, will be eligible for participation in this study. Patients will be screened and selected from the population of people with strokes who are seen in the Stanford Neuroscience Clinic. Patients will be allowed to participate in any scheduled outpatient rehabilitation during the study. The doctor and/or research coordinator may introduce the study to potential candidates in-person in the Stanford Neurology Clinic, and the research coordinator may contact potential candidates by phone after the doctor's referral. Procedures: Once the participant has given informed consent and enrolled in the study, they will have a total of five visits, with one visit every two weeks. Visit one will entail the participant and identified caregiver undergoing training on the use of the Smart Glove by the research coordinator and Neofect staff. This involves donning/doffing of the glove as well as instruction as to how to use the software program. The participant will be issued a Smart Glove and a tablet preloaded with the software. Subjects will also undergo baseline functional testing, including manual muscle testing (MMT), Fugl-Meyer assessment (FM), Jebsen-Taylor hand function test (JTT), and Stroke Impact Scale (SIS). This first visit is expected to take 60-90 minutes. The participant will be expected to use the Smart Glove for 60 min per day for at least 5 days per week. The subsequent three visits will be at two week intervals and will involve the participant bringing the device to the Clinical and Translational Research Unit (CTRU). The research coordinator will upload the data from the device as well as troubleshoot any device-related issues. These visits will last 15-30 minutes each. The final visit will occur after eight weeks of Smart Glove use. In addition to downloading the data, the research coordinator will also repeat functional testing functional testing, including manual muscle testing (MMT), Fugl-Meyer assessment (FM), Jebsen-Taylor hand function test (JTT), and Stroke Impact Scale (SIS). This visit will last 45-60 minutes.
Interventions
DEVICERAPAEL Smart Glove
The RAPAEL 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 is made of an elastomer material that is simple to maintain and clean. The Bending Sensor is a variable resistor that changes as it is bent. The sensor is a 9-axis movement and position sensor that consists of 3 acceleration channels, 3 angular rate channels, and 3 magnetic field channels that measure wrist movements. They are connected to a computer system which can accurately compute the amount of individual finger movements.
Sponsors
NEOFECT Rehabilitation Solutions
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Age 18 and older 2) Diagnosis of stroke at least three months prior to enrollment 3) Unilateral upper extremity functional deficit after stroke 4) Presence of a score of at least 2 points on the medical research council scale for wrist flexion/extension or forearm pronation/supination 5) Able to provide informed consent 6) Caregiver who is willing to be trained in use of the Smart Glove
Exclusion criteria
* 1\) Predisposing psychological disorders which could impede participation 2) Severe aphasia resulting in communication difficulties 3) Severe pain impeding upper extremity rehabilitation 4) Pre-existing neurological disorder that causes motor deficits (i.e. Parkinson's disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Use | 8 weeks | Number of days during 8 week study-period that patient used the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Use Daily Average | 8 weeks | Daily average number of minutes of device-use during 8-week intervention period. |
| Jebsen-Taylor Hand Function Test - Overall Score | 8 weeks | Time (in seconds) to complete the total Jebsen-Taylor Hand Function Test administered at 8-weeks. The test consists of 7 subtests. Each subtest is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the seven subtests. The total score has a maximum of 630 seconds and there is no minimum. Longer time to complete the test indicates worse hand function. |
| Jebsen-Taylor Hand Function Test - Fine Score | 8 weeks | Time (in seconds) to complete the four fine-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the four subtests is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the four subtests. The total score has a maximum of 360 seconds and there is no minimum. Longer time to complete the test indicates worse hand function. |
| Jebsen-Taylor Hand Function Test - Gross Score | 8 weeks | Time (in seconds) to complete the three gross-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the three gross-motor subtests is allotted a maximum time of 90 seconds. The total gross-motor score is the sum of the scores of the three subtests. The total score has a maximum of 270 seconds and there is no minimum. Longer time to complete the test indicates worse hand function. |
| Device Use Daily Average Per Use Day | 8 weeks | Daily average number of minutes of device-use per days that device was used. |
| Manual Muscle Testing (MMT) Score | 8 weeks | The MMT score is the sum of the Medical Research Council (MRC) scores across 5 domains (elbow flexor, elbow extensor, wrist extension, finger extension and finger flexion) at 8 weeks. Each domain has a scale range of 0 to 5, with higher scores corresponding to better strength. Maximum MMT score ranges from 0-25, with higher scores corresponding to better strength. |
| Stroke Impact Scale (SIS) | 8 weeks | Score on the SIS at 8-weeks. The score ranges from 0 to 100, with higher scores corresponding to better recovery from stroke. |
| Patient Experience | 8 weeks | Patient self-reported satisfaction with device use (5-point Likert Scale, with higher scores indicating greater satisfaction). |
| Fugl-Meyer Assessment | 8 weeks | Upper Extremity Fugl-Meyer Test score at 8-weeks. Score ranges from 0 to 66, with higher scores corresponding to better arm function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm - Intervention Arm RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week) | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Arm - Intervention Arm |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fugl-Meyer Assessment | 41 score on a scale STANDARD_DEVIATION 11 |
| Jebsen Hand Function Test Fine-Motor Score | 239 seconds STANDARD_DEVIATION 104 |
| Jebsen Hand Function Test Gross-Motor Score | 141 seconds STANDARD_DEVIATION 104 |
| Jebsen Hand Function Test Overall Score | 379 seconds STANDARD_DEVIATION 203 |
| Manual Muscle Testing (MMT) Score | 9.6 score on a scale STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
| Stroke Impact Scale (SIS) | 65 score on a scale STANDARD_DEVIATION 12 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Device Use
Number of days during 8 week study-period that patient used the device.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Device Use | 27 days | Standard Deviation 34 |
Secondary
Device Use Daily Average
Daily average number of minutes of device-use during 8-week intervention period.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Device Use Daily Average | 16.0 minutes | Standard Deviation 15.4 |
Secondary
Device Use Daily Average Per Use Day
Daily average number of minutes of device-use per days that device was used.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Device Use Daily Average Per Use Day | 27 minutes | Standard Deviation 16 |
Secondary
Fugl-Meyer Assessment
Upper Extremity Fugl-Meyer Test score at 8-weeks. Score ranges from 0 to 66, with higher scores corresponding to better arm function.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Fugl-Meyer Assessment | 43 score on a scale | Standard Deviation 12 |
p-value: 0.098paired t-test
Secondary
Jebsen-Taylor Hand Function Test - Fine Score
Time (in seconds) to complete the four fine-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the four subtests is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the four subtests. The total score has a maximum of 360 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Jebsen-Taylor Hand Function Test - Fine Score | 217 seconds | Standard Deviation 105 |
p-value: 0.01paired t-test
Secondary
Jebsen-Taylor Hand Function Test - Gross Score
Time (in seconds) to complete the three gross-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the three gross-motor subtests is allotted a maximum time of 90 seconds. The total gross-motor score is the sum of the scores of the three subtests. The total score has a maximum of 270 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Jebsen-Taylor Hand Function Test - Gross Score | 135 seconds | Standard Deviation 108 |
p-value: 0.3paired t-test
Secondary
Jebsen-Taylor Hand Function Test - Overall Score
Time (in seconds) to complete the total Jebsen-Taylor Hand Function Test administered at 8-weeks. The test consists of 7 subtests. Each subtest is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the seven subtests. The total score has a maximum of 630 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Jebsen-Taylor Hand Function Test - Overall Score | 353 seconds | Standard Deviation 208 |
p-value: 0.025paired t-test
Secondary
Manual Muscle Testing (MMT) Score
The MMT score is the sum of the Medical Research Council (MRC) scores across 5 domains (elbow flexor, elbow extensor, wrist extension, finger extension and finger flexion) at 8 weeks. Each domain has a scale range of 0 to 5, with higher scores corresponding to better strength. Maximum MMT score ranges from 0-25, with higher scores corresponding to better strength.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Manual Muscle Testing (MMT) Score | 10.0 score on a scale | Standard Deviation 3.4 |
p-value: 0.2paired t-test
Secondary
Patient Experience
Patient self-reported satisfaction with device use (5-point Likert Scale, with higher scores indicating greater satisfaction).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Patient Experience | 4.38 score on a scale | Standard Deviation 0.5 |
Secondary
Stroke Impact Scale (SIS)
Score on the SIS at 8-weeks. The score ranges from 0 to 100, with higher scores corresponding to better recovery from stroke.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm - Intervention Arm | Stroke Impact Scale (SIS) | 71 score on a scale | Standard Deviation 11 |
p-value: 0.07paired t-test