Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Procedure: VR immersive therapy

• Registration Number: NCT05728866
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

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 Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Study Start: 2023-03-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality (VR) therapy	VR immersive therapy	-

Primary Outcome Measures

Name	Time	Method
Change in hemiplegic arm movements	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States