Computer-based Training on Cognitive Dysphagia in Stroke Survivors

NCT06328816 | Not Yet Recruiting

• 1 other identifier: Computer-based Training
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The coordination of swallowing

  day 1 and day 15

• Penetration-Aspiration Scale

  day 1 and day 15

• Swallowing reflex

  day 1 and day 15

Study Arms (2)

routine rehabilitation treatment+Computer-assisted Cognitive Function Training

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.

Behavioral: routine rehabilitation treatment; Behavioral: Computer-assisted Cognitive Function Training

routine rehabilitation treatment

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.

Behavioral: routine rehabilitation treatment

Interventions

routine rehabilitation treatment BEHAVIORAL

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.

routine rehabilitation treatment; routine rehabilitation treatment+Computer-assisted Cognitive Function Training

Computer-assisted Cognitive Function Training BEHAVIORAL

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

routine rehabilitation treatment+Computer-assisted Cognitive Function Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Meeting the diagnostic criteria for traumatic brain injury.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copka Sonpashan: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Nieto Luis

  Site Coordinator of United Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lavie Ce

CONTACT

15333828388; linchuangzhuce@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Research Director

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 25, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03