Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04942847
Other study ID # 2020-721
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2022

Study information

Verified date May 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 128
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Cognitive card
To measure the patient's ability to focus, to calculate, to remember and to judge

Locations

Country Name City State
China 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China Hangzhou Zhejaing

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05849363 - A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination N/A
Completed NCT04598841 - Nutrition Support for Hirschsprung Disease N/A
Completed NCT05705336 - Clinical Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery. Phase 4
Recruiting NCT03698812 - A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis
Recruiting NCT05072678 - Clinical and Radiological Evaluation of Two Mastoid Filling Products
Completed NCT05308511 - Evaluating the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewing Colon Images N/A