跳至主要内容
临床试验/NCT06224517
NCT06224517招募中不适用

The Improvement in Pulse Wave Velocity and Its Correlation With Clinical Outcomes in Subacute Stroke Patients Following Rehabilitation

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
brachial-ankle pulse wave velocity

研究概览

简要总结

Currently, the literature regarding the relationship between Pulse Wave Velocity (PWV) and functional recovery, particularly of upper limb function, in patients with subacute stroke is still limited. Therefore, the aim of the study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.

详细描述

Objectives: The purpose of this study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.

Background: Arterial stiffness, increasing with age, is a significant risk factor for atherosclerotic diseases and a predictor of mortality from various causes, including symptomatic strokes. The brachial-ankle pulse wave velocity (baPWV), a reliable measure of arterial stiffness, correlates with cardiovascular events and mortality risk. Clinical improvements post-ischemic stroke align with a decrease in PWV, emphasizing arterial stiffness's role in recovery. Previous studies indicate significant differences in pressure waveforms and baPWV between stroke patients and control groups. Despite evidence of baPWV's prognostic value in predicting functional outcomes after acute cerebral infarction, the literature on its relation to functional recovery, especially upper limb function, in subacute stroke patients remains limited.

Study Design: Twenty-five patients admitted to the Department of Physical Medicine and Rehabilitation Medicine at Shin-Kong Wu Ho Su Memorial Hospital will be enrolled prospectively. Demographic and baseline clinical data, including age, gender, stroke duration (day), lesion side, stroke type, underlying disease, severity of neurological deficit (NIHSS) at admission were recorded. Once their neurological symptoms have stabilized, all patients will have their baPWV and functional outcome measurements before and four weeks after undergoing intensive rehabilitation therapy.

Methods: Inclusion criteria are as follows: first-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging; sufficient cognition to understand procedures and provide informed consent. Exclusion criteria are as follows: hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance; concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.), brain tumor, malignancy, limb deficiency or amputation.

The intervention includes daily physical and occupational therapy sessions tailored to each patient's functional status. In this study, stroke patients will undergo a four-week rehabilitation therapy program comprising 60-minute daily sessions of physical and occupational therapy. The physical therapy includes balance training, mobility and strengthening exercises, while occupational therapy covers sensorimotor and fine motor training, and ADL activities. The primary outcome is baPWV, measured noninvasively using an oscillometric method. Patients maintain their prescribed medication regime throughout. Secondary outcomes assessed include activities of daily living, balance, gait function, ambulation, and upper limb function.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging
  • Sufficient cognition to understand procedures and provide informed consent.

排除标准

  • Hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance
  • Concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.)
  • Brain tumor
  • Malignancy
  • Limb deficiency or amputation

结局指标

主要结局

brachial-ankle pulse wave velocity

时间窗: 4-week

baPWV is measured noninvasively using an oscillometric method (HBP-8000, Omron, Japan). The participants are required to abstain from caffeine for at least three hours prior to the test. The participant will be asked to rest in a supine position for a minimum of 10 minutes. Following this rest period, oscillometric cuffs were attached at the midway points of both arms and ankles for the simultaneous measurement of volume pulse and blood pressure. The arm-to-ankle distance was determined based on the patient's height. The baPWV was then computed by dividing the arm-ankle distance by the pulse time interval. The blood pressure analysis utilized the instantaneous systolic and diastolic blood pressure readings taken at the time of the baPWV measurement. For analytical purposes, an average of the values from both the left and right sides will be used.

次要结局

  • Activities of daily living(4-week)
  • Gait function and ambulation(4-week)
  • Balance(4-week)
  • Upper limb function(4-week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Chen Kuo

Principal Investigator

Shin Kong Wu Ho-Su Memorial Hospital

研究点 (1)

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