NCT06401564 · Stony Brook University
Virtual Reality Based Rehabilitation After Ischemic Stroke
What this study is about
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.
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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.
Interventions
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.
Primary outcome measures
Feasibility survey
Time frame: After each session up to 5 weeks
The User Satisfaction Evaluation Questionnaire (USEQ) is a 14-item questionnaire evaluating satisfaction on a scale from 1 (not at all) to 5 (severely).
Simulator sickness questionnaire
Time frame: After each session up to 5 weeks
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Where
- Stony Brook, New York
Collaborators
Good Samaritan Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2024 · Source of record for eligibility and locations