Condition or disease | Intervention/treatment | Phase |
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Prospective Study | Device: Sucking trainer Device: Cognitive card | Not Applicable |
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 (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 |
Arm | Intervention/treatment |
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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
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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.
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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
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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Zhejaing | |
2nd Affiliated Hospital,School of Medicine,Zhejiang University,China | |
Hangzhou, Zhejaing, China |
Principal Investigator: | Qiaomin Tang | 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China |
Tracking Information | |||||
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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 |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention |
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Condition ICMJE | Prospective Study | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |
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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 |