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Clinical Trials/NCT06215729
NCT06215729
Withdrawn
Not Applicable

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

Zeng Changhao1 site in 1 countryJanuary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphagia
Sponsor
Zeng Changhao
Locations
1
Primary Endpoint
Montreal Cognitive Assessment
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
April 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Montreal Cognitive Assessment

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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