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

NCT ID: NCT05148052

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional therapy first

Group receiving conventional occupational therapy first and then virtual reality exergames.

Group Type EXPERIMENTAL

Virtual reality exergames

Intervention Type DEVICE

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.

Conventional occupational therapy

Intervention Type BEHAVIORAL

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.

Virtual reality first

Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.

Group Type EXPERIMENTAL

Virtual reality exergames

Intervention Type DEVICE

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.

Conventional occupational therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

National Traffic Injury Rehabilitation Hospital

UNKNOWN

Sponsor Role collaborator

Korea Workers' Compensation and Welfare Service Incheon Hospital

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Gil Seo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han Gil Seo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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National Traffic Injury Rehabilitation Hospital

Yangp'yŏng, Gyeonggi-do, South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Han Gil Seo, MD, PhD

Role: CONTACT

82-2-2072-1659

Facility Contacts

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Ja-Ho Leigh

Role: primary

82-10-2871-9245

Han Gil Seo, MD, PhD

Role: primary

82-2-2072-1659

Seung Hak Lee, MD, PhD

Role: primary

Other Identifiers

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Stroke-VR-U/Ex

Identifier Type: -

Identifier Source: org_study_id

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