Virtual Reality Based Rehabilitation After Ischemic Stroke

NCT ID: NCT06401564

Last Updated: 2024-05-06

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2026-12-31

Brief Summary

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The goal of this single-arm study is to explore the use of early virtual reality-based rehabilitation as an adjunct to conventional physical/occupational therapy in adult patients with acute ischemic stroke. The main question it aims to answer is:

Feasibility and tolerability of using immersive Virtual Reality technology-based therapy for patients suffering from acute ischemic stroke in an inpatient hospital setting Participants will receive 1 or 2 virtual reality therapy sessions and complete surveys at the end of each session.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Therapy

Group Type EXPERIMENTAL

Virtual Reality Therapy

Intervention Type DEVICE

Each participant will receive one or two 20 minute VR sessions during their admission. Participants are able to pause or discontinue at any time. During each VR session, participants will use the REAL Immersive VR system and be equipped with a VR headset and 6 sensors attached to the torso, waist, and upper extremities. Patient will then undergo various virtual challenges guided by the physical or occupational therapist facilitating movements of the upper extremity, core, head, and neck.

Interventions

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Virtual Reality Therapy

Each participant will receive one or two 20 minute VR sessions during their admission. Participants are able to pause or discontinue at any time. During each VR session, participants will use the REAL Immersive VR system and be equipped with a VR headset and 6 sensors attached to the torso, waist, and upper extremities. Patient will then undergo various virtual challenges guided by the physical or occupational therapist facilitating movements of the upper extremity, core, head, and neck.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* MRI or CT imaging confirmed ischemic stroke
* Able to follow multistep commands

Exclusion Criteria

* Plegia in both arms
* Previous reported history of vertigo or inner ear dysfunction
* Patients with epilepsy
* Patients who cannot begin therapy during admission
* Patients who are pregnant
* Patients with a pre-existing condition that interferes with virtual reality usage (e.g., visual impairment, limitation of either upper extremity or neck).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Good Samaritan Hospital

UNKNOWN

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Jason Mathew

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Mathew, DO

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Hospital

Locations

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Stony Brook University Hospital

Stony Brook, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Pol, PhD

Role: CONTACT

(631) 444-9083

Ruth Reinsel, PhD

Role: CONTACT

(631) 638-2087

Facility Contacts

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Christine Pol

Role: primary

631-444-9083

Other Identifiers

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IRB2021-00237

Identifier Type: -

Identifier Source: org_study_id

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