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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- upper limbs function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute ischemic stroke with ICD-10 codes: G45-G46.8, I63-I68.
- •Within 10 days (inclusive) of stroke symptom onset.
- •Age 18~85 years or older.
排除标准
- •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.
研究组 & 干预措施
Early intervention in patients with acute ischemic stroke
virtual reality-based interactive rehabilitation
干预措施: Virtual reality-based interactive rehabilitation (Device)
traditional rehabilitation.
traditional bedside rehabilitation.
干预措施: bedside rehabilitation (Behavioral)
结局指标
主要结局
upper limbs function
时间窗: 7days later
FMA-UE
cognitive status
时间窗: 7days later
SLUME
次要结局
- Change in Self-Efficacy for Exercise (SEE) Scale Score(Baseline and 7 days after intervention)
研究者
YUN QIAN LIN
Nurse Practitioner
Tri-Service General Hospital (TSGH)