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临床试验/NCT06361901
NCT06361901招募中不适用

Comparison of Therapeutic Effect and Brain Activity According to Language Rehabilitation Program and Language Therapy in Patients With Speech Impairment After Stroke. Prospective, Randomized, Single-blind, Exploratory Clinical Study

Korea University Guro Hospital2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2023年11月17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
20
试验地点
2
主要终点
Aphasic quatient

研究概览

简要总结

Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.

Clinical evaluation tools will be performed before and after the treatment for all patients

  • K-Western Aphasia Battery for aphasia assessment tools
  • Cerebral blood flow changes with near-infrared spectroscopy

详细描述

During the initial evaluation of this study, the patient's gender, age, and onset of stroke lesion occurrence are collected and a cognitive evaluation is performed. In addition, the K-Western Aphasia Battery for aphasia assessment tools(K-WAB) and Cerebral blood flow changes with near-infrared spectroscopy will be performed. All participants will be assigned to a test group or control group. In addition to the existing speech rehabilitation treatment, the test group will receive a speech rehabilitation program, and the control group will receive the same treatment as the existing speech rehabilitation treatment.

After treatment is completed, the K-WAB test and near-infrared spectroscopy will be performed again.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Adults over 19 years old
  • Those with speech disorders that occurred after a stroke was diagnosed
  • Those who can follow the clinical study procedures
  • Those who voluntarily signed the consent form

排除标准

  • Patients who have difficulty to consent to research and participate in speech rehabilitation programs due to cognitive decline

结局指标

主要结局

Aphasic quatient

时间窗: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.

Aphasic quatient using K-Western Aphasia Battery for aphasia assessment tools

次要结局

  • Change of cerebral blood flow(Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.)

研究者

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

Yang, Seung Nam

Professor

Korea University Guro Hospital

研究点 (2)

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