Implementation of IVS3 for Upper Limb Motor Recovery

NCT ID: NCT06483230

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Neglect, Hemispatial Stroke, Cardiovascular Mirror Movement Motor Activity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hemi-spatial Neglect

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

Group Type EXPERIMENTAL

Intensive Visual Stimulation Device

Intervention Type 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.

No hemi-spatial neglect

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

Group Type ACTIVE_COMPARATOR

Intensive Visual Stimulation Device

Intervention Type 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.

Interventions

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Intensive Visual Stimulation 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.

Intervention Type DEVICE

Other Intervention Names

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IVS3 (model number 2022.02.IVS3.013)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Spasticity or increased tone with MAS ≥3 in the upper extremity
2. Unable to communicate effectively or provide informed consent
3. Significant visual impairments
4. Concurrent occupational therapy being received outside of the study
5. Pregnant or incarcerated individuals
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dessintey Inc.

UNKNOWN

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan Stilling, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Zhiyan Yang, MS

Role: CONTACT

(212) 746-1509

Facility Contacts

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Joan Stilling, MD

Role: primary

Other Identifiers

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24-04027379

Identifier Type: -

Identifier Source: org_study_id

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