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Status unknownNCT04942847Updated Jun 29, 2021

Application of Cognitive Combined Sucking Task Training in Dysphagia After Stroke

An interventional study of Sucking trainer and Cognitive card in Prospective Study, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-29.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Prospective Study

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03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's planned enrollment of 128 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
128 participants (estimated)

Study arms

  • 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 · Device: Cognitive card

Interventions

  • DeviceSucking trainer

    Repeated sucking for tongue flexibility training can improve the tongue muscle's ability to control and transmit food, and improve the swallowing function.

  • DeviceCognitive card

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 8 hours after admission and 7 days after admission

  2. 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.

    Time frame: Within 8 hours after admission and 7 days after admission

07

Study locations

1 site
  • 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
    Hangzhou, Zhejaing, China
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04942847
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jun 29, 2021
Start date
Oct 1, 2020
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jun 29, 2021

Study contacts

Qiaomin Tang
principal investigator · 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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