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临床试验/NCT06303882
NCT06303882Unknown不适用

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

Muhammad0 个研究点目标入组 80 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
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
Single (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.
  • 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.

研究组 & 干预措施

Computer-assisted Cognitive Function Training+routine rehabilitation treatment

Experimental

In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment. The experimental group additionally underwent computer-assisted cognitive training, which generated training content of corresponding difficulty based on the patient's cognitive impairment assessment results. The training was conducted seven days a week, once a day, for a duration of 30-45 minutes per session.

干预措施: routine rehabilitation treatment (Behavioral)

Computer-assisted Cognitive Function Training+routine rehabilitation treatment

Experimental

In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment. The experimental group additionally underwent computer-assisted cognitive training, which generated training content of corresponding difficulty based on the patient's cognitive impairment assessment results. The training was conducted seven days a week, once a day, for a duration of 30-45 minutes per session.

干预措施: Computer-assisted Cognitive Function Training (Behavioral)

routine rehabilitation treatment+conventional cognitive training

Active Comparator

In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment.The control group was given conventional cognitive training.

干预措施: routine rehabilitation treatment (Behavioral)

routine rehabilitation treatment+conventional cognitive training

Active Comparator

In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment.The control group was given conventional cognitive training.

干预措施: conventional cognitive training (Behavioral)

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 The total score ranged from 0 to 30.

次要结局

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

研究者

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

Muhammad

Research Director

Ahmadu Bello University Teaching Hospital

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