Ischemic StrokeNCT06401564
Virtual Reality Based Rehabilitation After Ischemic Stroke
A study testing Virtual Reality Therapy in people with Ischemic Stroke, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Virtual Reality Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- MRI or CT imaging confirmed ischemic stroke
- Able to follow multistep commands
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794-8121
Christine Pol, 631-444-9083, christiana.pol@stonybrookmedicine.edu
About this study
Official title: Improving Functional and Cognitive Outcomes After Ischemic Stroke Using Virtual Reality Based Rehabilitation
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
- Being tested
- Virtual Reality Therapy
- Keywords
- virtual reality, stroke rehabilitation, quality of life, upper extremity
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Therapy | Experimental | Not described Receives: Device: Virtual Reality Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: After each session up to 5 weeks
Secondary outcomes (5)
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
Measured: 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).
Measured: 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.
Measured: Hospital discharge, an average of 7 days
Duration of sessions
Actual time spent using the Virtual Reality (VR) system
Measured: After each session up to 1 week
Time spent by therapist
Time spent by therapist assisting patient including set-up.
Measured: After each session up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start17 Apr 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Good Samaritan Hospital
- Responsible party
- Principal investigator, Jason Mathew, Stony Brook University
- Investigators
- Jason Mathew, DO, Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401564
- Sponsor's protocol ID
- IRB2021-00237
- Status last verified
- May 2024
- First submitted
- 2 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functional and Cognitive Outcomes After Ischemic Stroke Using Virtual Reality Based Rehabilitation
- ClinicalTrials.gov ID
- NCT06401564
- Acronym / sponsor ID
- IRB2021-00237
- Conditions
- Ischemic Stroke
- Keywords
- virtual reality, stroke rehabilitation, quality of life, upper extremity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Good Samaritan Hospital
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Therapy | Experimental | Device: Virtual Reality Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- MRI or CT imaging confirmed ischemic stroke
- Able to follow multistep commands
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality TherapyEach 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. | Device | Virtual Reality Therapy |
Primary outcome
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).
5 secondary outcomes
Adverse events
Time frame: After each session up to 5 weeks
NIHSS
Time frame: Hospital discharge, an average of 7 days
Modified Rankin Scale (mRS)
Time frame: Hospital discharge, an average of 7 days
Duration of sessions
Time frame: After each session up to 1 week
Time spent by therapist
Time frame: After each session up to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Mathew, DO principal investigator
Stony Brook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Therapy in people with Ischemic Stroke, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Pol, PhD ((631) 444-9083, christiana.pol@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility survey (time frame: After each session up to 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.