About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
Any current drug or alcohol abuse
History of recurrent or unprovoked seizures
Any neurological disorder treatments that involve intracranial surgery or device implantation
Trial design
Crossover
Treatments tested in this trial
Active Vibrotactile coordinated reset
DeviceParticipants 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.
Sham vibrotactile coordinated reset
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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
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.
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
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: