Clinical trial NCT06328816: Computer-based Training on Cognitive Dysphagia in Stroke Survivors
Official title: The Therapeutic Effect of Computer-based Training on Cognitive Dysphagia in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: day 1 and day 15
Secondary outcomes:
measure: The coordination of swallowing
timeFrame: day 1 and day 15
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 15
measure: Swallowing reflex
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis
role: PRINCIPAL_INVESTIGATOR
References: