The Therapeutic Effect of Computer-assisted Cognitive Function Training on Cognitive Dysphagia After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06215729
• Other study ID #: 2023-KY-1229
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

Behavioral:
• routine rehabilitation treatment
The routine rehabilitation treatment included intervention for risk factors (such as blood pressure, blood lipids, and blood glucose control, restriction of smoking and alcohol, exercise, etc.) Besides, the patients with stable vital signs were scheduled for specialized rehabilitation training upon enrollment, and targeted rehabilitation programs were selected, conducted by experienced rehabilitation therapists.
• conventional cognitive training
including Memory training, attention training, and executive function training were conducted 2-5 times per week, lasting for 30-60 minutes each session, based on the patient's condition.
• Computer-assisted Cognitive Function Training
Based on the patient's cognitive impairment assessment results, the training content includes Attention game training, Executive function program training, Logical reasoning training, Agility training, Memory training. The training is conducted seven days a week, once a day, for a duration of 30-45 minutes per session

Locations

Country	Name	City	State
China	Zheng da yi fu yuan hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment	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	day 1 and day 15
Secondary	The coordination of swallowing	Observation of the coordination of laryngeal and vocal fold movements. Results are categorized as normal/abnormal.	day 1 and day 15
Secondary	Penetration-Aspiration Scale	Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.	day 1 and day 15
Secondary	Swallowing duration	The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the was recorded.Unit: seconds.	day 1 and day 15
Secondary	Swallowing reflex	Observation of the ability to initiate swallowing movements during eating, manifested by the white-out phenomenon seen under flexible laryngoscopy. Results are categorized as normal or abnormal.	day 1 and day 15