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出境医 / 临床实验 / Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke

Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke

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.

Condition or disease Intervention/treatment Phase
Prospective Study Device: Sucking trainer Device: Cognitive card Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  1. Change from Baseline Cognitive function at 7 days [ Time Frame: Within 8 hours after admission and 7 days after admission ]
    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.

  2. Change from Baseline Swallowing function at 7 days [ Time Frame: Within 8 hours after admission and 7 days after admission ]
    (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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
China, Zhejaing
2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
Hangzhou, Zhejaing, China
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Layout table for investigator information
Principal Investigator: Qiaomin Tang 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
Tracking Information
First Submitted Date  ICMJE May 29, 2021
First Posted Date  ICMJE June 29, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2021)
  • Change from Baseline Cognitive function at 7 days [ Time Frame: Within 8 hours after admission and 7 days after admission ]
    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 [ Time Frame: Within 8 hours after admission and 7 days after admission ]
    (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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke
Official Title  ICMJE Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Prospective Study
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Sucking trainer
    • Device: Cognitive card
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 20, 2021)
128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04942847
Other Study ID Numbers  ICMJE 2020-721
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qiaomin Tang 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP