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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Behavioral: routine rehabilitation treatment; Behavioral: Computer-assisted Cognitive Function Training; Behavioral: conventional 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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lavie Ce, Master; Phone Number: 15333828388; Email: zenghongjixx@qq.com

Study Locations

• Thailand
  • Bangkok, Thailand
    • Thai-Z Uni Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer-assisted Cognitive Function 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 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.	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.; Behavioral: 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
Active Comparator: routine rehabilitation treatment+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.	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 The total score ranged from 0 to 30.	day 1 and day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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. The higher scores indicating worse swallowing function The total score ranged from 0 to 8.	day 1 and day 15

Collaborators and Investigators

• Sponsor: Muhammad
• Investigators: Study Chair: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: AI-Dysphagia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No