Effectiveness of IVR Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke

NCT05728866 | Completed

• 1 other identifier: HM20025720
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to approximately 12 days

Study Arms (1)

Virtual reality (VR) therapy

EXPERIMENTAL

Procedure: VR immersive therapy

Interventions

VR immersive therapy PROCEDURE

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.

Virtual reality (VR) therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Virginia Chu, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: March 12, 2023
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)