Clinical trial NCT06215729: The Therapeutic Effect of Computer-assisted Cognitive Function Training on Cognitive Dysphagia After Stroke
Official title: The Therapeutic Effect of Computer-assisted Cognitive Function Training on Cognitive Dysphagia After Stroke: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dysphagia
Cognitive Impairment
Stroke
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 0
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, 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.

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 duration
timeFrame: day 1 and day 15
measure: Swallowing reflex
timeFrame: day 1 and day 15
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng da yi fu yuan hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: