Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke

this topic research, on the basis of traditional swallowing training to develop a set of scientific and advanced type of swallowing disorder in patients with stroke rehabilitation training of the new strategy, combined with cognitive training and sucking training for swallowing disorder in patients with cerebral apoplexy and to provide professional, systematic and comprehensive rehabilitation guidance, promote patients early recovery and return to society.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prospective Study
• Intervention / Treatment: Device: Sucking trainer; Device: Cognitive card

Detailed Description

The incidence of dysphagia in stroke patients is as high as 30% ~ 65%. Dysphagia caused by stroke is the primary cause of dysphagia and an independent risk factor for the prognosis of patients. The rehabilitation of cognitive function is the key to the assessment of swallowing and the recovery of rehabilitation function after stroke, and complete consciousness, sensorimotor consciousness and motivation are the prerequisites for the rehabilitation of swallowing function. Traditional rehabilitation programs focus more on the single task training of patients' function and ignore the training of cognitive function. Cognitive deglutition dual task training is a kind of cognitive rehabilitation training at the same time of deglutition rehabilitation treatment. In this study, the "dual task" training mode of cognitive combined sucking training was applied to the rehabilitation of patients with swallowing dysfunction after stroke, to evaluate the rehabilitation of patients with swallowing function and cognitive function, and to further guide the clinical development and implementation of early rehabilitation treatment and nursing.

Expected results:

Through this topic research, on the basis of traditional swallowing training to develop a set of scientific and advanced type of swallowing disorder in patients with stroke rehabilitation training of the new strategy, combined with cognitive training and sucking training for swallowing disorder in patients with cerebral apoplexy and to provide professional, systematic and comprehensive rehabilitation guidance, promote patients early recovery and return to society.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejaing
    • Hangzhou, Zhejaing, China
      • 2nd affiliated Hospital,School of Medicine,Zhejiang University,China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Acute stroke
• Clinical diagnosis of Deglutition disorders
• Must be able to communicate through reading and writing

Exclusion Criteria:

• Dysphagia not caused by stroke Patients
• With important organ failure or critical illness
• Severe mental illness or cognitive impairment
• Severe oropharyngeal organic disease

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The control group; The control group received routine nursing, including diet nursing, life nursing, direct and indirect training, health education and so on. Patients were followed up regularly by telephone after discharge
Experimental: Dual task training group; On the basis of routine swallowing function training, the use of sucking training rehabilitation device is mainly used for tongue muscle training and lip muscle training to improve the control and delivery ability of tongue muscle to food.At the same time,adopt Troup's playing and comprehensive analysis ability training.Disrupt the three sets of cards, instruct the patient to read words or say colors, and measure the patient's reaction time with an electronic timer.Comprehensive analysis ability training: including digital training or item classification training.	Device: Sucking trainer; Repeated sucking for tongue flexibility training can improve the tongue muscle's ability to control and transmit food, and improve the swallowing function.; Device: Cognitive card; To measure the patient's ability to focus, to calculate, to remember and to judge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Cognitive function at 7 days	MMSE(Mini-mental State Examination) score, composed of 20 questions, can be used to evaluate orientation, attention, calculation ability, long-term and short-term memory and judgment ability. The score ranges from 0 to 30, The lower the score, the more serious the cognitive impairment.	Within 8 hours after admission and 7 days after admission
Change from Baseline Swallowing function at 7 days	(Swallowing-Quality of Life)SWALQO score. has 44 items, which are used to evaluate 11 aspects of quality of life of patients with dysphagia.the total score was converted into 0-100. 0 means that the quality of life is extremely low, 100 means that the quality of life is normal, and the higher the score, the higher the quality of life.	Within 8 hours after admission and 7 days after admission

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Qiaomin Tang, 2nd affiliated Hospital,School of Medicine,Zhejiang University,China

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 29, 2021
• First Submitted That Met QC Criteria: June 20, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 20, 2021
• Last Verified: May 1, 2021

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: 2020-721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

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