Implementation of IVS3 for Upper Limb Motor Recovery

Weill Cornell Medicine (WCM)

Status: Enrolling

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

Treatments: Device: Intensive Visual Stimulation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06483230

24-04027379

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Hemi-spatial Neglect

Experimental group

Description:

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

Treatment:

Device: Intensive Visual Stimulation Device

No hemi-spatial neglect

Active Comparator group

Description:

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

Treatment:

Device: Intensive Visual Stimulation Device