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Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke

Primary Purpose

Prospective Study

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sucking trainer
Cognitive card
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prospective Study

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

The control group

Dual task training group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2021
Last Updated
June 20, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04942847
Brief Title
Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke
Official Title
Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prospective Study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
No Intervention
Arm Description
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
Arm Title
Dual task training group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sucking trainer
Intervention Description
Repeated sucking for tongue flexibility training can improve the tongue muscle's ability to control and transmit food, and improve the swallowing function.
Intervention Type
Device
Intervention Name(s)
Cognitive card
Intervention Description
To measure the patient's ability to focus, to calculate, to remember and to judge
Primary Outcome Measure Information:
Title
Change from Baseline Cognitive function at 7 days
Description
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.
Time Frame
Within 8 hours after admission and 7 days after admission
Title
Change from Baseline Swallowing function at 7 days
Description
(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.
Time Frame
Within 8 hours after admission and 7 days after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiaomin Tang
Organizational Affiliation
2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
City
Hangzhou
State/Province
Zhejaing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke

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