NCT04942847

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 29, 2021

Status Verified

May 1, 2021

Enrollment Period

2.2 years

First QC Date

May 29, 2021

Last Update Submit

June 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

The control group

NO INTERVENTION

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

Dual task training group

EXPERIMENTAL

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 trainerDevice: Cognitive card

Interventions

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

Dual task training group

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

Dual task training group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Dysphagia not caused by stroke Patients
  • With important organ failure or critical illness
  • Severe mental illness or cognitive impairment
  • Severe oropharyngeal organic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejaing, China

Location

Study Officials

  • Qiaomin Tang

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2021

First Posted

June 29, 2021

Study Start

October 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 29, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Locations