Implementation of IVS3 for Upper Limb Motor Recovery

NCT06483230 | Recruiting DMC FDA Device

• 1 other identifier: 24-04027379
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neglect, Hemispatial; Stroke, Cardiovascular; Mirror Movement; Motor Activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mean Client Satisfaction Questionnaire-8

  Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)

• Mean System Usability Scale (SUS)

  Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)

Other Outcomes (5)

• Mean Star Ratio on Star Cancellation Test

  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

  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)

  Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)

Study Arms (2)

Hemi-spatial Neglect

EXPERIMENTAL

Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests.

Device: Intensive Visual Stimulation Device

No hemi-spatial neglect

ACTIVE COMPARATOR

Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests.

Device: Intensive Visual Stimulation Device

Interventions

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.

Also known as: IVS3 (model number 2022.02.IVS3.013)

Hemi-spatial Neglect; No hemi-spatial neglect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• English speaking
• History of ischemic or hemorrhagic stroke ≥ 6 months prior to study enrolment
• FMA-UE: 20 \< x \< 50 (moderate impairments)
• With or without hemi spatial neglect

You may not qualify if:

• Spasticity or increased tone with MAS ≥3 in the upper extremity
• Unable to communicate effectively or provide informed consent
• Significant visual impairments
• Concurrent occupational therapy being received outside of the study
• Pregnant or incarcerated individuals

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Dessintey Inc.: collaborator

Study Sites (1)

Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Perceptual Disorders; Myocardial Infarction; Motor Activity

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Behavior

Study Officials

• Joan Stilling, MD,MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyan Yang, MS

CONTACT

(212) 746-1509; zhy7009@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 24 months following study publication
• Access Criteria: 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.

Locations

US (1)