Virtual Reality Based Rehabilitation After Ischemic Stroke

NCT06401564 | Recruiting

• 1 other identifier: IRB2021-00237
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Use the template below as a guide to write a brief study description in plain language. Tailor the text that appears in brackets and yellow to your research study. To finalize, delete the text in italics. 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.

Conditions

Ischemic Stroke

Keywords

virtual reality; stroke rehabilitation; quality of life; upper extremity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Adverse events

  After each session up to 5 weeks

• NIHSS

  Hospital discharge, an average of 7 days

• Modified Rankin Scale (mRS)

  Hospital discharge, an average of 7 days

• Duration of sessions

  After each session up to 1 week

• Time spent by therapist

  After each session up to 1 week

Study Arms (1)

Virtual Reality Therapy

EXPERIMENTAL

Device: Virtual Reality Therapy

Interventions

Virtual Reality Therapy 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.

Virtual Reality Therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stony Brook University: lead
• Good Samaritan Hospital: collaborator

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794-8121, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jason Mathew, DO

  Stony Brook University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Pol, PhD

CONTACT

(631) 444-9083; christiana.pol@stonybrookmedicine.edu

Ruth Reinsel, PhD

CONTACT

(631) 638-2087; ruth.reinsel@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: May 6, 2024
• Study Start: April 17, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)