Implementation of IVS3 for Upper Limb Motor Recovery
NCT Number: NCT06483230
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neglect, Hemispatial|Stroke, Cardiovascular|Mirror Movement|Motor Activity
Interventions: DEVICE: Intensive Visual Stimulation Device
Sponsor: Weill Medical College of Cornell University
Collaborators: Dessintey Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-06
Locations: Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106, New York, New York, 10065, United States

Summary:
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.

Primary Outcome Measures: 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.
Secondary Outcome Measures: 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 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)|Mean System Usability Scale (SUS), 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 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)
Other Outcome Measures: 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, Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, 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 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, 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 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, 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 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, 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 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)