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临床试验/NCT06215729
NCT06215729撤回不适用

The Therapeutic Effect of Computer-assisted Cognitive Function Training on Cognitive Dysphagia After Stroke: A Randomized Controlled Study

Zeng Changhao1 个研究点 分布在 1 个国家开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Montreal Cognitive Assessment

研究概览

简要总结

This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

详细描述

Computer-assisted cognitive training is a rehabilitation method that uses computer technology and psychological principles to promote the recovery of cognitive function.This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age ≥ 18 years.
  • Meeting the diagnostic criteria for traumatic brain injury, confirmed by magnetic resonance imaging or CT scan.
  • Montreal Cognitive Assessment score < 26 and > 18 (adjusted by 1 point if the educational level is high school graduation or above).
  • Confirmed swallowing disorder through Fiberoptic Endoscopic Examination of Swallowing.
  • Duration of illness greater than three months.
  • Patients or their family members are aware of and consent to participate in the study.

排除标准

  • Presence of other intracranial lesions, such as stroke.
  • Cognitive impairment caused by other diseases.
  • Mental abnormalities.
  • Inability to complete treatment and assessments due to other impairments.
  • Concurrent severe injuries.

结局指标

主要结局

Montreal Cognitive Assessment

时间窗: day 1 and day 15

The Montreal Cognitive Assessment is used for assessing cognitive function.The total score on the test is 30, the higher scores indicating the higher cognitive function

次要结局

  • The coordination of swallowing(day 1 and day 15)
  • Penetration-Aspiration Scale(day 1 and day 15)
  • Swallowing duration(day 1 and day 15)
  • Swallowing reflex(day 1 and day 15)

研究者

发起方
Zeng Changhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

研究点 (1)

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