Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Study Overview
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Brief Summary
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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 in stoke patients This study will include a dedicated sham that will aid in understanding true treatment effects from vCR

Official Title
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Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Conditions
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Chronic Stroke

Intervention / Treatment
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* Device: Active Vibrotactile coordinated reset
* Device: Sham vibrotactile coordinated reset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at the time of enrollment: 18-80 years Diagnosis of ischemic or hemorrhagic stroke Disease period of more than 6 months Mini mental state examination of at least 24 points No medications that effect balance Motor deficit Use of Motricity Arm and Leg index to include impaired individuals with some functioning Modified Rankin Scale for Neurologic Disability: Scores 3 or 4 Exclusion Criteria: 1. Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression 2. Any current drug or alcohol abuse 3. History of recurrent or unprovoked seizures 4. Any neurological disorder treatments that involve intracranial surgery or device implantation 5. Participation in another drug, device or biologic trial concurrently or within the preceding days 6. Pregnancy, breastfeeding or wanting to become pregnant during the trial 7. History or presence of other major neurological or orthopedic diseases other than stroke that limits motor functioning or cognitive ability 8. History of previous stroke 9. More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle 10. Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months 11. Must be able to communicate with staff 12. Severe sensory abnormalities of the fingers such as vibratory urticaria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Vibrotactile Coordinated Reset (vCR)<br>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. | Device: Active Vibrotactile coordinated reset<br>* 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.<br>|
| Sham Comparator: Sham Vibrotactile Coordinated Reset (vCR)<br>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. | Device: Sham vibrotactile coordinated reset<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |