Virtual Reality Based Rehabilitation After Ischemic Stroke

Improving Functional and Cognitive Outcomes After Ischemic Stroke Using Virtual Reality Based Rehabilitation

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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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Virtual Reality Therapy

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Pol, PhD; Phone Number: (631) 444-9083; Email: christiana.pol@stonybrookmedicine.edu
• Study Contact Backup: Name: Ruth Reinsel, PhD; Phone Number: (631) 638-2087; Email: ruth.reinsel@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794-8121
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Christine Pol; Phone Number: 631-444-9083; Email: christiana.pol@stonybrookmedicine.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Reality Therapy

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility survey	The User Satisfaction Evaluation Questionnaire (USEQ) is a 14-item questionnaire evaluating satisfaction on a scale from 1 (not at all) to 5 (severely).	After each session up to 5 weeks
Simulator sickness questionnaire	An evaluation tool for assessing the subjective severity of simulator sickness symptoms. A 16-item questionnaire evaluating different symptoms on a scale from 0 (not at all) to 4 (severe).	After each session up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Frequency of adverse events such as dizziness, lightheadedness, nausea, headache, falls, fatigue, or other symptoms prompting program termination prior to end of a single 20-minute session	After each session up to 5 weeks
NIHSS	NIHSS is a standardized method that uses a 42-point scale to measure the level of impairment caused by a stroke. The 42-point scale measures several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language (0 = no stroke and 42 = severe stroke).	Hospital discharge, an average of 7 days
Modified Rankin Scale (mRS)	The mRS incorporates mental as well as physical adaptations to the neurological deficits. It measures independence rather than performance of specific tasks. The mRS includes 15 items and takes approximately six minutes to complete. Scales consists of seven grades, from zero to six, with zero corresponding to no symptoms and six corresponding to death.	Hospital discharge, an average of 7 days
Duration of sessions	Actual time spent using the Virtual Reality (VR) system	After each session up to 1 week
Time spent by therapist	Time spent by therapist assisting patient including set-up.	After each session up to 1 week

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Good Samaritan Hospital
• Investigators: Principal Investigator: Jason Mathew, DO, Stony Brook University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; virtual reality; upper extremity; stroke rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: IRB2021-00237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No