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| Name | Class |
|---|---|
| Dessintey Inc. | UNKNOWN |
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This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.
This study will investigate the implementation of the intensive visual stimulation three (IVS3) device in the outpatient rehabilitation setting. This is a phase I/II open label study that will assess participant satisfaction and upper extremity function in outpatients with chronic stroke (10 with hemi spatial neglect and 15 without), when exposed to IVS3 for 30 minutes and conventional treatment for 15 minutes, across 12 sessions in 4-6 weeks at Weill Cornell medicine outpatient rehabilitation (single site).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemi-spatial Neglect | Experimental | Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests. |
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| No hemi-spatial neglect | Active Comparator | Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Visual Stimulation Device | Device | The therapist installs the patient in front of the device. First, patient puts the healthy side on the table and the therapist records several movements. The software of the device flips the video in order to create a mirrored image of the movement (pretty close to the mirror therapy approach). When all the movements are recorded, patient installs the affected side on the table and the screen is placed over the hand. Likewise, patient has the impression the hand is moving again. Thanks to this action observation principle, therapist can encourage the patient in trying to move again and increase brain plasticity. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of sessions attended | The primary outcome measure is defined as the mean number of sessions attended of the planned twelve visits. Min 0, Max 12. | 12 treatment sessions over 4-6 weeks. |
| Number of serious adverse events | The primary outcome for safety is defined as the number of serious adverse events that occur while using the IVS3 device. | 12 treatment sessions over 4-6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Client Satisfaction Questionnaire-8 | Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction. | Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15) |
| Mean System Usability Scale (SUS) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Star Ratio on Star Cancellation Test | Screening tool to detect unilateral spatial neglect. The maximum score that can be achieved on the test is 54 points (56 small stars in total minus the 2 used for demonstration). A cutoff of < 44 indicates the presence of USN. A Laterality Index or Star Ratio can be calculated from the ratio of stars cancelled on the left of the page to the total number of stars cancelled. Scores between 0 and 0.46 indicate USN in the left hemispace. Scores between 0.54 and 1 indicate USN in the right hemispace |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyan Yang, MS | Contact | (212) 746-1509 | zhy7009@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joan Stilling, MD,MS | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106 | Recruiting | New York | New York | 10065 | United States |
Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures).
Beginning 9 months and ending 24 months following study publication
Investigators whose proposed use of data has been approved by an independent review committee for individual participant data meta-analyses. Data will be available 2 years following study publication.
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| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D009203 | Myocardial Infarction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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Feasibility. This tool is a subjective therapist usability measure assessing satisfaction with implementation of the intervention. It is a 10 item likert scale, scored 0-100, with higher scores indicating greater satisfaction. |
| Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15) |
| Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15) |
| Mean Distance from Midpoint on Line Bisection | Screening tool to detect unilateral spatial neglect. Patients are asked to place a mark with a pencil (with their preferred or unaffected hand) through the center of a series of 18 horizontal lines on an 11x 8.5-inch page. The test is scored by measuring the deviation of the bisection from the true center of the line. A deviation of more than 6 mm from the midpoint indicates USN. Omission of two or more lines on one half of the page indicates USN. | Baseline, Post- treatment, 3 months post-treatment.Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15) |
| Mean Change from baseline Fugl-Meyer Upper Extremity Assessment (FMAUE) | Assessment of upper extremity motor function. 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. Score ranges from 0-66 for the upper extremity (22 items). | Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15) |
| Mean Change from baseline Action Research Arm Test (ARAT) | The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.The ARAT is scored on a four-level ordinal scale (0-3). 0 = can not perform any part of the test, 1 = performs the test partially, 2 = completes the test, but takes abnormally long time, 3 = performs the test normally. Total score ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. | Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15) |
| Mean change from baseline numeric pain rating scale (NPRS) | The NPRS measures the subjective intensity of pain. The NPRS is an 11-point scale scored from 0-10: 1) "0" = no pain, 2) "10" = the most intense pain imaginable. | Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15) |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D001519 | Behavior |