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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT05148052
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-08
• Study Start: 2022-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

National Traffic Injury Rehabilitation Hospital; 🇰🇷 Yangpyeong, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of