StrokeNCT05728866
Effectiveness of IVR Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke
A study testing VR immersive therapy in people with Stroke, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to understand the efficacy of using an immersive Virtual Reality (VR) environment, with task-specific training, to encourage arm movement following stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- VR immersive therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2023to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or older.
- Diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment.
- Lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury.
- At the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior.
- Participants will not participate in Yoga, Tai-Chi, or other wellness lifestyle classes while participating in the study.
- Absence of significant cognitive impairment as determined by a Mini-Mental Status Examination score of greater than or equal to 24.
- The absence of upper extremity injury limiting functional use of the arm prior to the incident stroke.
Who cannot join
- Unable to provide informed consent.
- Sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale.
- Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale.
- History of greater than two strokes.
- Suffered a stroke less than 6-months prior to participating in the study.
- A history of, or being susceptible to, cyber-sickness (i.e., motion sickness).
- Unable to don/doff accelerometer independently, or the lack of support in the home to assist with donning/doffing device; and
- A history of seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Effectiveness of Immersive Virtual Reality (IVR) Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.
The purpose of this research study is to understand the efficacy of using an immersive Virtual Reality (VR) environment, with task-specific training, to encourage arm movement following stroke.
Read the detailed description
The study will investigate how people who have had a stroke use their weakened arm in everyday tasks, and how this relates to measurements of movement ability from standardized clinic tests. Results of this research will ultimately help develop more effective training approaches to be used with stroke survivors.
- Conditions
- Stroke
- Being tested
- VR immersive therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR immersive therapyProcedure or surgery
Participants will be asked to participate in 5 consecutive, 1-hour, 1:1 therapy sessions focused on rehabilitation of their weakened arm. Each session will involve use of a Virtual Reality (VR) system to deliver an immersive environment to encourage movement of the arm. The system also relies on 6 body-worn sensors that will detect movements of participant's arms and trunk. VR use will encompass 30-minutes of the therapy session, the remainder of the session will involve working with the therapist in addressing the functional tasks that are most meaningful for the participant and that involve the upper extremities.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) therapy | Experimental | Not described Receives: Procedure: VR immersive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemiplegic arm movements
Arm movements will be measured using wrist-worn accelerometers. Amount of movement will be measured prior to and following the intervention
Measured: Baseline to approximately 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start12 Mar 2023
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Chu, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728866
- Sponsor's protocol ID
- HM20025720
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2023
- Last updated
- 19 Mar 2026
- Results posted
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immersive Virtual Reality (IVR) Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.
- ClinicalTrials.gov ID
- NCT05728866
- Acronym / sponsor ID
- HM20025720
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 15 Feb 2023 (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.
The purpose of this research study is to understand the efficacy of using an immersive Virtual Reality (VR) environment, with task-specific training, to encourage arm movement following stroke.
Detailed description
The study will investigate how people who have had a stroke use their weakened arm in everyday tasks, and how this relates to measurements of movement ability from standardized clinic tests. Results of this research will ultimately help develop more effective training approaches to be used with stroke survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) therapy | Experimental | Procedure: VR immersive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older.
- Diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment.
- Lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury.
- At the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior.
- Participants will not participate in Yoga, Tai-Chi, or other wellness lifestyle classes while participating in the study.
Key exclusion criteria (8 listed)
- Unable to provide informed consent.
- Sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale.
- Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale.
- History of greater than two strokes.
- Suffered a stroke less than 6-months prior to participating in the study.
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 |
|---|---|---|
| VR immersive therapyParticipants will be asked to participate in 5 consecutive, 1-hour, 1:1 therapy sessions focused on rehabilitation of their weakened arm. Each session will involve use of a Virtual Reality (VR) system to deliver an immersive environment to encourage movement of the arm. The system also relies on 6 body-worn sensors that will detect movements of participant's arms and trunk. VR use will encompass 30-minutes of the therapy session, the remainder of the session will involve working with the therapist in addressing the functional tasks that are most meaningful for the participant and that involve the upper extremities. | Procedure or surgery | Virtual reality (VR) therapy |
Primary outcome
Change in hemiplegic arm movements
Time frame: Baseline to approximately 12 days
Arm movements will be measured using wrist-worn accelerometers. Amount of movement will be measured prior to and following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. This study is not recruiting at the moment.
Virginia Chu, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR immersive therapy in people with Stroke, run by Virginia Commonwealth 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 19 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemiplegic arm movements (time frame: Baseline to approximately 12 days). 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 19 Mar 2026.