NCT07674329

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Mar 2025Oct 2026

Study Start

First participant enrolled

March 7, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

May 6, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • upper limbs function

    FMA-UE

    7days later

  • cognitive status

    SLUME

    7days later

Secondary Outcomes (1)

  • Change in Self-Efficacy for Exercise (SEE) Scale Score

    Baseline and 7 days after intervention

Study Arms (2)

Early intervention in patients with acute ischemic stroke

EXPERIMENTAL

virtual reality-based interactive rehabilitation

Device: Virtual reality-based interactive rehabilitation

traditional rehabilitation.

EXPERIMENTAL

traditional bedside rehabilitation.

Behavioral: bedside rehabilitation

Interventions

Virtual reality

Early intervention in patients with acute ischemic stroke

traditional bedside rehabilitation

traditional rehabilitation.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri Service General Hospital

Taipei, 224, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeAnxiety Disorders

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMental Disorders

Study Officials

  • YUN QIAN LIN

    Tri-Service General Hospital (TSGH)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Chen LIN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Practitioner

Study Record Dates

First Submitted

May 6, 2026

First Posted

June 29, 2026

Study Start

March 7, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations