StrokeNCT05148052
Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.
A study testing Virtual reality exergames and Conventional occupational therapy in people with Stroke, run by Seoul National University Hospital at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual reality exergames and Conventional occupational therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 1 Sep 2022to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
National Traffic Injury Rehabilitation Hospital
Yangpyeong, Gyeonggi-do, 12564
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Virtual reality exergames, Conventional occupational therapy
- Keywords
- Stroke, Virtual reality, Upper Extremity Paresis
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exergamesDevice
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy first | Experimental | Group receiving conventional occupational therapy first and then virtual reality exergames. Receives: Device: Virtual reality exergames; Behavioral: Conventional occupational therapy |
| Virtual reality first | Experimental | Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy. Receives: Device: Virtual reality exergames; Behavioral: Conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.
Measured: Within 2 days after the end of each intervention
Secondary outcomes (6)
Box and Block test
an upper extremity function evaluation tool
Measured: Within 2 days after the end of each intervention
Fugl-Meyer (FM) Assessment
an upper extremity function evaluation tool
Measured: Within 2 days after the end of each intervention
Modified Barthel Index
an evaluation tool for assessing activities of daily living
Measured: 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
Measured: 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
Measured: Within 2 days after the end of each intervention
Simulator Sickness Questionnaire
an evaluation tool for assessing the subjective severity of simulator sickness symptoms
Measured: Day 1 and Day 12 of virtual reality exergames intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Sep 2022
- Primary completion31 Aug 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, National Traffic Injury Rehabilitation Hospital, Korea Workers' Compensation and Welfare Service Incheon Hospital
- Responsible party
- Principal investigator, Han Gil Seo, Seoul National University Hospital
- Investigators
- Han Gil Seo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148052
- Sponsor's protocol ID
- Stroke-VR-U/Ex
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05148052
- Acronym / sponsor ID
- Stroke-VR-U/Ex
- Conditions
- Stroke
- Keywords
- Stroke, Virtual reality, Upper Extremity Paresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, National Traffic Injury Rehabilitation Hospital, Korea Workers' Compensation and Welfare Service Incheon Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy first | Experimental | Device: Virtual reality exergames, Behavioral: Conventional occupational therapyGroup receiving conventional occupational therapy first and then virtual reality exergames. |
| Virtual reality first | Experimental | Device: Virtual reality exergames, Behavioral: Conventional occupational therapyGroup receiving virtual reality exergames with virtual reality first and then conventional occupational therapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exergamesTwelve 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. | Device | Conventional therapy first, Virtual reality first |
| Conventional occupational therapyConventional 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. | Behavioural | Conventional therapy first, Virtual reality first |
Primary outcome
Action Research Arm Test
Time frame: 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.
6 secondary outcomes
Box and Block test
Time frame: Within 2 days after the end of each intervention
Fugl-Meyer (FM) Assessment
Time frame: Within 2 days after the end of each intervention
Modified Barthel Index
Time frame: Within 2 days after the end of each intervention
Grip strength
Time frame: Within 2 days after the end of each intervention
Beck Depression Inventory (BDI)
Time frame: Within 2 days after the end of each intervention
Simulator Sickness Questionnaire
Time frame: Day 1 and Day 12 of virtual reality exergames intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Gil Seo, MD, PhD principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exergames and Conventional occupational therapy in people with Stroke, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (time frame: Within 2 days after the end of each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.