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

NCT06215729 | Withdrawn DMC

• 1 other identifier: 2023-KY-1229
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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; Cognitive Impairment; Stroke

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 (4)

• 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 Arms (2)

the experimental group

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

the control group

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; Behavioral: conventional cognitive training

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.

the control group; the experimental group

conventional cognitive training BEHAVIORAL

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.

the control group

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

the experimental group

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, 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.

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

• Zeng Changhao: lead

Study Sites (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Deglutition Disorders; Cognitive Dysfunction; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: January 15, 2024
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)