- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05728866
- Original Trial
Effectiveness of IVR Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke
March 17, 2026 updated by: Virginia Commonwealth University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality (VR) therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline to approximately 12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Virginia Chu, PhD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2023
Primary Completion (Actual)
November 20, 2025
Study Completion (Actual)
November 20, 2025
Study Registration Dates
First Submitted
February 6, 2023
First Submitted That Met QC Criteria
February 6, 2023
First Posted (Actual)
February 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 17, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20025720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.