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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06401564
Other study ID # IRB2021-00237
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 17, 2023
Est. completion date December 2026

Study information

Verified date May 2024
Source Stony Brook University
Contact Christine Pol, PhD
Phone (631) 444-9083
Email christiana.pol@stonybrookmedicine.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Stony Brook University Hospital Stony Brook New York

Sponsors (2)

Lead Sponsor Collaborator
Stony Brook University Good Samaritan Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Duration of sessions Actual time spent using the Virtual Reality (VR) system After each session up to 1 week
Secondary Time spent by therapist Time spent by therapist assisting patient including set-up. After each session up to 1 week
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