Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.

Effect of Upper Extremity Rehabilitation Using Fully-immersive Virtual Reality for Motor Recovery in Chronic Stroke Patients: A Prospective, Multicenter, Single-blind, Explorative, Randomized Crossover Trial

The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Virtual reality exergames; Behavioral: Conventional occupational therapy

Detailed Description

This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Fifteen chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.

*Due to recruitment challenges, the anticipated enrollment has been revised from 36 to 15.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Gyeonggi-do
    • Yangp'yŏng, Gyeonggi-do, South Korea, 12564
      • National Traffic Injury Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke
• Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic)
• Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively
• Patients who can stably maintain a sitting position
• Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

• Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE)
• Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc.
• Patients with a history of severe vertigo or epilepsy
• Patients with medical reasons such as medical conditions that make it difficult to participate in research
• Patients who may be pregnant or who are pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional therapy first; Group receiving conventional occupational therapy first and then virtual reality exergames.	Device: Virtual reality exergames; Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.; Behavioral: Conventional occupational therapy; Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.
Experimental: Virtual reality first; Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.	Device: Virtual reality exergames; Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.; Behavioral: Conventional occupational therapy; Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test	As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.	Within 2 days after the end of each intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block test	an upper extremity function evaluation tool	Within 2 days after the end of each intervention
Fugl-Meyer (FM) Assessment	an upper extremity function evaluation tool	Within 2 days after the end of each intervention
Modified Barthel Index	an evaluation tool for assessing activities of daily living	Within 2 days after the end of each intervention
Grip strength	Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter	Within 2 days after the end of each intervention
Beck Depression Inventory (BDI)	an evaluation tool for severity of depression in normal and psychiatric populations	Within 2 days after the end of each intervention
Simulator Sickness Questionnaire	an evaluation tool for assessing the subjective severity of simulator sickness symptoms	Day 1 and Day 12 of virtual reality exergames intervention

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; National Traffic Injury Rehabilitation Hospital; Korea Workers' Compensation and Welfare Service Incheon Hospital
• Investigators: Principal Investigator: Han Gil Seo, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Virtual reality; Upper Extremity Paresis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Paresis
• Other Study ID Numbers: Stroke-VR-U/Ex

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No