Acute Ischemic StrokeNCT07674329
Effectiveness of Early Intervention With Virtual Reality-Based Interactive Rehabilitation on Upper Extremity Muscle Strength, Cognitive Status, Hospital Anxiety, and Exercise Self-Efficacy in Patients With Acute Ischemic Stroke
A study testing Virtual reality-based interactive rehabilitation and bedside rehabilitation in people with Acute Ischemic Stroke, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This interventional study evaluates the impact of early virtual rehabilitation, starting 24 hours post-diagnosis of acute ischemic stroke, on upper limb strength, cognitive status, and self-efficacy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Virtual reality-based interactive rehabilitation and bedside rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Mar 2025to 1 Oct 2026
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute ischemic stroke with ICD-10 codes: G45-G46.8, I63-I68.8.
- Within 10 days (inclusive) of stroke symptom onset.
- Age 18~85 years or older.
Who cannot join
- Comorbid neuromuscular or orthopedic conditions affecting upper limb function.)
- Recurrence of stroke or onset of seizures during the study period.
- Severe visual impairment or visuospatial neglect.
- Inability to cooperate or refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hui-Chen LIN contact
Taiwan1 site, 1 recruiting
- Recruiting
Tri Service General Hospital
Taipei, 224
YUN QIAN LIN, 0933513418 ext. 88044, yurilin0709@gmail.com
YUN QIAN LIN, 28973311 ext. 88044, yurilin0709@gmail.com
About this study
Official title: Effectiveness of Early Intervention With Virtual Reality-based Interactive Rehabilitation on Upper Extremity Muscle Strength, Cognitive Status, Hospital Anxiety and Exercise Self-efficacy in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
This interventional study evaluates the impact of early virtual rehabilitation, starting 24 hours post-diagnosis of acute ischemic stroke, on upper limb strength, cognitive status, and self-efficacy. The goal is to establish more effective rehabilitation protocols for acute ischemic stroke patients and to boost their motivation to participate in training.
Read the detailed description
Project Title:
Effectiveness of Early Intervention Using a Virtual Reality Motion-Sensing Rehabilitation System on Improving Upper Limb Muscle Strength, Cognitive Status, and Self-Efficacy in Patients with Acute Ischemic Stroke
- Project Description This study is divided into two groups: the experimental group and the control group. The experimental group will utilize a Virtual Reality (VR) motion-sensing rehabilitation APP, while the control group will receive traditional rehabilitation. The study aims to verify the outcomes and evaluate the effectiveness of early rehabilitation intervention using the VR motion-sensing APP in patients with acute ischemic stroke.
The planned sample size is 50 participants for the experimental group and 50 participants for the traditional rehabilitation group, totaling 100 participants. The recruitment sites are the Neurology Wards and the Stroke and Neurointensive Care Unit (SNICU) of Tri-Service General Hospital. The total duration of the study, including data analysis, is approximately one year.
II. Research Objectives Current research on rehabilitation training for patients after acute ischemic stroke predominantly focuses on the period from the post-acute phase up to six months. The primary objective of this study is to explore the effects of providing early virtual rehabilitation intervention-initiated 24 hours after a confirmed diagnosis of acute ischemic stroke-on the improvement of upper limb muscle strength, cognitive status, and the enhancement of patients' self-efficacy. By investigating these objectives, the study aims to provide a more effective method for early rehabilitation intervention during the acute phase of ischemic stroke and to boost patients' motivation for rehabilitation training.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Virtual reality-based interactive rehabilitation, bedside rehabilitation
- Keywords
- Virtual reality, acute ischemic stroke, early rehabilitation, upper limb muscle strength, cognitive status, self-efficacy, anxiety
- Medical subject headings
- Ischemic Stroke, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality-based interactive rehabilitationDevice
Virtual reality
bedside rehabilitationBehavioural
traditional bedside rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Early intervention in patients with acute ischemic stroke | Experimental | virtual reality-based interactive rehabilitation Receives: Device: Virtual reality-based interactive rehabilitation |
| traditional rehabilitation. | Experimental | traditional bedside rehabilitation. Receives: Behavioral: bedside rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper limbs function
FMA-UE
Measured: 7days later
cognitive status
SLUME
Measured: 7days later
Secondary outcomes (1)
Change in Self-Efficacy for Exercise (SEE) Scale Score
Self-efficacy will be assessed using the Self-Efficacy for Exercise (SEE) Scale. The SEE is a 10-item questionnaire that evaluates participants' confidence in their ability to continue exercising under various circumstances. Total scores range from 10 to 40, with higher scores indicating greater exercise self-efficacy.
Measured: Baseline and 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start7 Mar 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants in the experimental group will receive rehabilitation intervention using the Active Arcade application. They will perform interactive exercises on a tablet to complete combined motor and cognitive training. The control group will receive traditional bedside rehabilitation. Both groups will initiate their respective interventions 24 hours after admission. Pre- and post-test evaluations will be conducted for both groups to assess the effectiveness of the interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUN QIAN LIN, Tri-Service General Hospital (TSGH)
- Investigators
- YUN QIAN LIN, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674329
- Sponsor's protocol ID
- C202405171
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is currently in progress. Once the results are finalized, they will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Intervention With Virtual Reality-based Interactive Rehabilitation on Upper Extremity Muscle Strength, Cognitive Status, Hospital Anxiety and Exercise Self-efficacy in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07674329
- Acronym / sponsor ID
- C202405171
- Conditions
- Acute Ischemic Stroke
- Keywords
- Virtual reality, acute ischemic stroke, early rehabilitation, upper limb muscle strength, cognitive status, self-efficacy, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 29 Jun 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.
This interventional study evaluates the impact of early virtual rehabilitation, starting 24 hours post-diagnosis of acute ischemic stroke, on upper limb strength, cognitive status, and self-efficacy. The goal is to establish more effective rehabilitation protocols for acute ischemic stroke patients and to boost their motivation to participate in training.
Detailed description
Project Title:
Effectiveness of Early Intervention Using a Virtual Reality Motion-Sensing Rehabilitation System on Improving Upper Limb Muscle Strength, Cognitive Status, and Self-Efficacy in Patients with Acute Ischemic Stroke
- Project Description This study is divided into two groups: the experimental group and the control group. The experimental group will utilize a Virtual Reality (VR) motion-sensing rehabilitation APP, while the control group will receive traditional rehabilitation. The study aims to verify the outcomes and evaluate the effectiveness of early rehabilitation intervention using the VR motion-sensing APP in patients with acute ischemic stroke.
The planned sample size is 50 participants for the experimental group and 50 participants for the traditional rehabilitation group, totaling 100 participants. The recruitment sites are the Neurology Wards and the Stroke and Neurointensive Care Unit (SNICU) of Tri-Service General Hospital. The total duration of the study, including data analysis, is approximately one year.
II. Research Objectives Current research on rehabilitation training for patients after acute ischemic stroke predominantly focuses on the period from the post-acute phase up to six months. The primary objective of this study is to explore the effects of providing early virtual rehabilitation intervention-initiated 24 hours after a confirmed diagnosis of acute ischemic stroke-on the improvement of upper limb muscle strength, cognitive status, and the enhancement of patients' self-efficacy. By investigating these objectives, the study aims to provide a more effective method for early rehabilitation intervention during the acute phase of ischemic stroke and to boost patients' motivation for rehabilitation training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in the experimental group will receive rehabilitation intervention using the Active Arcade application. They will perform interactive exercises on a tablet to complete combined motor and cognitive training. The control group will receive traditional bedside rehabilitation. Both groups will initiate their respective interventions 24 hours after admission. Pre- and post-test evaluations will be conducted for both groups to assess the effectiveness of the interventions.
| Arm | Type | Receives |
|---|---|---|
| Early intervention in patients with acute ischemic stroke | Experimental | Device: Virtual reality-based interactive rehabilitationvirtual reality-based interactive rehabilitation |
| traditional rehabilitation. | Experimental | Behavioral: bedside rehabilitationtraditional bedside rehabilitation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of acute ischemic stroke with ICD-10 codes: G45-G46.8, I63-I68.8.
- Within 10 days (inclusive) of stroke symptom onset.
- Age 18~85 years or older.
Key exclusion criteria (4 listed)
- Comorbid neuromuscular or orthopedic conditions affecting upper limb function.)
- Recurrence of stroke or onset of seizures during the study period.
- Severe visual impairment or visuospatial neglect.
- Inability to cooperate or refusal to participate in the study.
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-based interactive rehabilitationVirtual reality | Device | Early intervention in patients with acute ischemic stroke |
| bedside rehabilitationtraditional bedside rehabilitation | Behavioural | traditional rehabilitation. |
Primary outcome
upper limbs function
Time frame: 7days later
FMA-UE
cognitive status
Time frame: 7days later
SLUME
1 secondary outcome
Change in Self-Efficacy for Exercise (SEE) Scale Score
Time frame: Baseline and 7 days after intervention
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 29 Jun 2026.
- Individual participant dataSharing planned: Undecided. The study is currently in progress. Once the results are finalized, they will be shared.
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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.
Hui-Chen LIN contact
YUN QIAN LIN principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality-based interactive rehabilitation and bedside rehabilitation in people with Acute Ischemic Stroke, run by Tri-Service General Hospital (TSGH) 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 3 inclusion and 4 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 29 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 YUN QIAN LIN (28973311 ext. 88044, yurilin0709@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper limbs function (time frame: 7days later). The study lists 2 primary outcomes in all. 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 29 Jun 2026.