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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07674329
Enrollment
100
Registered
2026-06-29
Start date
2025-03-07
Completion date
2026-10-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

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

Brief 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.

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.

Interventions

DEVICEVirtual reality-based interactive rehabilitation

Virtual reality

traditional bedside rehabilitation

Sponsors

Tri-Service General Hospital (TSGH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
upper limbs function7days laterFMA-UE
cognitive status7days laterSLUME

Secondary

MeasureTime frameDescription
Change in Self-Efficacy for Exercise (SEE) Scale ScoreBaseline and 7 days after interventionSelf-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.

Countries

Taiwan

Contacts

CONTACTYUN QIAN LIN
yurilin0709@gmail.com28973311
CONTACTHui-Chen LIN
cecilia@tmu.edu.tw
PRINCIPAL_INVESTIGATORYUN QIAN LIN

Tri-Service General Hospital (TSGH)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026