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The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients. vCR will be administered with a device called the Vibrotactile (VT) Brain Glove. vCR is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. This study will include a dedicated sham arm that will aid in understanding true treatment effects from vCR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Vibrotactile Coordinated Reset (vCR) | Active Comparator | Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain. |
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| Sham Vibrotactile Coordinated Reset (vCR) | Sham Comparator | Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Vibrotactile coordinated reset | Device | Participants will receive active vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. | This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |
| Neuro Quality of Life Upper Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months | The Neuro quality of life upper extremity short form test measures the functionality of upper extremities. This is a self-report questionnaire that has a Likert scale from 1 to 5, with 5 indicating no difficulties and 1 indicating unable to do. Total possible points are out of 40, with a higher score indicating better upper extremity abilities. | This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months | The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Functional categories may be scored from 0 to 1, 0 to 2, or 0 to 3, depending on the item. Total scores range from 0 to 20, with lower scores indicating increased disability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Yankulova | Contact | 650-474-9547 | jessky@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter A Tass, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94303 | United States |
Individual participant data is deidentified and may be shared with other researchers upon request
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|
| Sham vibrotactile coordinated reset | Device | Participants will receive sham vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR. |
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| This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |
| Action Research Arm Test change from baseline, 3 months, 4 months, 7months and 8 months | The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations.Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement). Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance. | This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |
| Timed Up and Go test change from baseline, 3 months, 4 months, 7months and 8 months | This test is a measure walking ability with correlates to balance and fall risk. The patient is timed using a stopwatch and the patient is instructed to walk as quickly as possible for 3 meters. The test is scored as such: ≤ 10 seconds = normal ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid ≤ 30 seconds = problems, cannot go outside alone, requires gait aid * A score of ≥ 14 seconds has been shown to indicate high risk of falls | This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |
| Neuro Quality of Life Lower Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months | The Neuro quality of life lower extremity short form test measures the functionality of upper extremities. This is a self-report questionnaire that has a Likert scale from 1 to 5, with 5 indicating no difficulties and 1 indicating unable to do. Total possible points are out of 40, with a higher score indicating better lower extremity abilities. | This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |
| Sensorimotor reaction time task | Patients receive vibratory stimuli on a finger and indicate when stimuli are felt by pressing a button. | This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |
| Vibratory temporal discrimination task | Patients receive vibratory stimuli on two fingers either simultaneously or at different times and indicate the perceived timing by pressing a button. | This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit |