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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

2026年6月23日 更新者:YUN QIAN LIN、Tri-Service General Hospital (TSGH)

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Early intervention in patients with acute ischemic stroke
virtual reality-based interactive rehabilitation
Virtual reality
实验性的:traditional rehabilitation.
traditional bedside rehabilitation.
traditional bedside rehabilitation

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
upper limbs function
大体时间:7days later
FMA-UE
7days later
cognitive status
大体时间:7days later
SLUME
7days later

次要结果测量

结果测量
措施说明
大体时间
Change in Self-Efficacy for Exercise (SEE) Scale Score
大体时间:Baseline and 7 days after intervention
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.
Baseline and 7 days after intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:YUN QIAN LIN、Tri-Service General Hospital (TSGH)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年3月7日

初级完成 (估计的)

2026年10月1日

研究完成 (估计的)

2026年10月1日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年6月23日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年6月29日

上次提交的符合 QC 标准的更新

2026年6月23日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The study is currently in progress. Once the results are finalized, they will be shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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