Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke

Not Applicable

Not yet recruiting

• Conditions: Dysphagia
• Interventions: Behavioral: routine rehabilitation treatment; Behavioral: Computer-assisted Cognitive Function Training; Behavioral: conventional cognitive training

• Registration Number: NCT06303882
• Lead Sponsor: Muhammad

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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-assisted Cognitive Function Training+routine rehabilitation treatment	routine rehabilitation treatment	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.
routine rehabilitation treatment+conventional cognitive training	routine rehabilitation treatment	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.
Computer-assisted Cognitive Function Training+routine rehabilitation treatment	Computer-assisted Cognitive Function Training	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.
routine rehabilitation treatment+conventional cognitive training	conventional cognitive training	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.

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment	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.

Secondary Outcome Measures

Name	Time	Method
The coordination of swallowing	day 1 and day 15	Observation of the coordination of laryngeal and vocal fold movements. Results are categorized as normal/abnormal.
Swallowing reflex	day 1 and day 15	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.
Swallowing duration	day 1 and day 15	The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the was recorded.Unit: seconds.
Penetration-Aspiration Scale	day 1 and day 15	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.; The higher scores indicating worse swallowing function The total score ranged from 0 to 8.