StrokeNCT07525713
Virtual Reality Mirror Therapy With Focused Object-Directed Attention System
A study testing task-oriented training in people with Stroke and Rehabilitation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In this study, the investigators hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Rehabilitation, Virtual Reality
- What is being tested?
- task-oriented training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stroke with unilateral side involved;
- A score of Mini-mental state examination greater than 24 for proving higher mental function;
- Time of onset > 6 months before treatment begins;
- Premorbid right-handedness.
Who cannot join
- Severe vision impairment;
- Major cognitive-perceptual deficit;
- Other brain disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, Taiwan, 704
Hsiu-Yun Hsu, 886-6-2353535 ext. 2669, hyhsu@mail.ncku.edu.tw
About this study
Official title: Virtual Reality Mirror Therapy With Focused Object-Directed Attention for Neuro-Rehabilitation
In this study, the investigators hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke.
The aim of this study is to compare the immediate effects of a single session of VRMT, VRMTFOA, and VRMTFOA with auditory feedback on upper extremity function and brain activity in stroke patients.
- Conditions
- Stroke, Rehabilitation, Virtual Reality, Mirror Movement Therapy, Attention, Task Performance
- Being tested
- task-oriented training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task-oriented trainingOther
Virtual Reality Mirror Therapy combined with Motor training targeted to goals that are relevant to the functional needs of the patient
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Mirror Therapy Group | Active comparator | 30 minutes of Virtual Reality Mirror Therapy combined with 20 minutes of conventional task-oriented therapy. Receives: Other: task-oriented training |
| Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) | Experimental | 30 minutes of Virtual Reality Mirror Therapy with Focused Object-Directed Attention combined with 20 minutes of conventional task-oriented therapy. Receives: Other: task-oriented training |
| VRMTFOA with auditory feedback | Active comparator | 30 minutes of VRMTFOA with auditory feedback combined with 20 minutes of conventional task-oriented therapy. Receives: Other: task-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
Measured: baseline, 9 weeks and 21 weeks
Secondary outcomes (6)
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by assess muscle tone by evaluating resistance to passive stretch, reflecting the level of spasticity, with scores ranging from 0 (no increase in tone) to 4 (rigidity in flexion or extension).
Measured: baseline, 9 weeks and 21 weeks
Change in the result of Box and blocks test
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Measured: baseline, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Measured: baseline, 9 weeks and 21 weeks
Change in the result of Motor Activity Log
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.
Measured: baseline, 9 weeks and 21 weeks
Surface electromyography (sEMG)
Change in the root mean square (RMS) of the EMG signal was computed to quantify the change of muscle activation.
Measured: baseline, 9 weeks
Clinical Global Impression (CGI) scale
Assess overall clinical change, rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525713
- Sponsor's protocol ID
- A-ER-114-469
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Mirror Therapy With Focused Object-Directed Attention for Neuro-Rehabilitation
- ClinicalTrials.gov ID
- NCT07525713
- Acronym / sponsor ID
- A-ER-114-469
- Conditions
- Stroke, Rehabilitation, Virtual Reality, Mirror Movement Therapy, Attention, Task Performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
In this study, the investigators hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke.
The aim of this study is to compare the immediate effects of a single session of VRMT, VRMTFOA, and VRMTFOA with auditory feedback on upper extremity function and brain activity in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Mirror Therapy Group | Active comparator | Other: task-oriented training30 minutes of Virtual Reality Mirror Therapy combined with 20 minutes of conventional task-oriented therapy. |
| Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) | Experimental | Other: task-oriented training30 minutes of Virtual Reality Mirror Therapy with Focused Object-Directed Attention combined with 20 minutes of conventional task-oriented therapy. |
| VRMTFOA with auditory feedback | Active comparator | Other: task-oriented training30 minutes of VRMTFOA with auditory feedback combined with 20 minutes of conventional task-oriented therapy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of stroke with unilateral side involved;
- A score of Mini-mental state examination greater than 24 for proving higher mental function;
- Time of onset > 6 months before treatment begins;
- Premorbid right-handedness.
Key exclusion criteria (3 listed)
- Severe vision impairment;
- Major cognitive-perceptual deficit;
- Other brain disease.
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 |
|---|---|---|
| task-oriented trainingVirtual Reality Mirror Therapy combined with Motor training targeted to goals that are relevant to the functional needs of the patient | Other | VRMTFOA with auditory feedback, Virtual Reality Mirror Therapy Group, Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) |
Primary outcome
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Time frame: baseline, 9 weeks and 21 weeks
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
6 secondary outcomes
Change in the result of Modified Ashworth scale (MAS)
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Box and blocks test
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Motor Activity Log
Time frame: baseline, 9 weeks and 21 weeks
Surface electromyography (sEMG)
Time frame: baseline, 9 weeks
Clinical Global Impression (CGI) scale
Time frame: 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing task-oriented training in people with Stroke and Rehabilitation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiu-Yun Hsu, Ph.D (886-6-2353535 ext. 2669, hyhsu@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test (time frame: baseline, 9 weeks and 21 weeks). 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 16 Jun 2026.