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RecruitingNCT07674329Updated Jun 29, 2026

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

An interventional study of Virtual reality-based interactive rehabilitation and bedside rehabilitation in Acute Ischemic Stroke, sponsored by Tri-Service General Hospital (TSGH). Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Tri-Service General Hospital (TSGH) · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2025, registered May 2026).
  • Started Mar 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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

I. 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.

02

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Virtual reality, acute ischemic stroke, early rehabilitation, upper limb muscle strength, cognitive status, self-efficacy, anxiety
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Tri-Service General Hospital (TSGH) is the lead sponsor of 38 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Early intervention in patients with acute ischemic stroke

    virtual reality-based interactive rehabilitation

    Device: Virtual reality-based interactive rehabilitation

  • Experimental
    traditional rehabilitation.

    traditional bedside rehabilitation.

    Behavioral: bedside rehabilitation

Interventions

  • DeviceVirtual reality-based interactive rehabilitation

    Virtual reality

  • Behavioralbedside rehabilitation

    traditional bedside rehabilitation

06

What researchers measure

Primary outcomes

  1. upper limbs function

    FMA-UE

    Time frame: 7days later

  2. cognitive status

    SLUME

    Time frame: 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.

    Time frame: Baseline and 7 days after intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — The study is currently in progress. Once the results are finalized, they will be shared.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Oct 2026, 18 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 18 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2026
First posted
Jun 29, 2026
StartActual
Mar 7, 2025
Primary completionEst.
Oct 1, 2026
CompletionEst.
Oct 1, 2026
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07674329
Lead sponsor
Tri-Service General Hospital (TSGH)
Responsible party
YUN QIAN LIN (Nurse Practitioner, Tri-Service General Hospital (TSGH)) — Principal investigator
First posted
Jun 29, 2026
Start date
Mar 7, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Jun 29, 2026

Study contacts

YUN QIAN LIN
Contact
yurilin0709@gmail.com
28973311 ext. 88044
Hui-Chen LIN
Contact
cecilia@tmu.edu.tw
YUN QIAN LIN
principal investigator · Tri-Service General Hospital (TSGH)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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