Back to results

A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke

Primary Purpose

Stroke

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

acupuncture

Liu-Zi-Jue Gongfa

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, dysphagia, rehabilitation, traditional Chinese medicine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Dysphagia
- Meet the diagnostic criteria of stroke in traditional Chinese medicine;
- Meet the diagnostic criteria of ischemic stroke in western medicine;
- meet the diagnostic criteria of pseudobulbar palsy;
- Age is 18-85, gender not limited;
- The course of disease is 30 to 180 days;
- Water test level 3 and level 3 above;
- Meet the requirements for indications of acupuncture and moxibustion techniques; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance;
- Sign informed consent
- MOCA（Montreal Cognitive Assessment） score above 15.

Exclusion Criteria:

Dysphagia
- Patients with true bulbar palsy caused by brainstem encephalitis, motor neurone disease, pontine tumor, multiple sclerosis, myasthenia gravis, medulla bulbar cavity;
- Cerebral hemorrhage caused by cerebrovascular malformation, trauma, aneurysm and other causes;
- Pregnant or lactating women;
- Patients with severe primary chronic diseases, severe dementia and cognitive impairment, serious language understanding disorders, and mental illness, including heart, liver, kidney and other viscera, as well as the endocrine system and hematopoietic system;
- Suffered from a variety of bleeding tendency diseases;
- The patient to swallow contrast drug allergy;
- Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, cannot judge the efficacy or incomplete data affect the judgment of efficacy and are not suitable for clinical observation;

Sites / Locations

The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting
Hangzhou hospital of traditional Chinese medicineRecruiting
Jiaxing hospital of Chinese traditional medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

control

Combination treatment

Liu-Zi-Jue treatment

acupuncture treatment

Arm Description

basic treatment+Swallowing rehabilitation training

basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation

basic treatment+Swallowing rehabilitation training+Liu-Zi-Jue

basic treatment+Swallowing rehabilitation training+acupuncture

Outcomes

Primary Outcome Measures

Standardized Swallowing Assessment

use Standardized Swallowing Assessment to evaluate the patient's conscious, lip closure control ability, the head and trunk control ability, the respiratory mode.

Secondary Outcome Measures

video fluoroscopic swallowing study score，VFSS score

Mainly includes oral stage, pharynx stage, the degree of pharynx three parts, oral stage for 0-2 points; The pharyngeal period was 0-3 points; The degree of pharynx error is 0-4 points, with a total score of 9 points for the sum of the three points. The higher the score, the better the swallowing function is.

The effective rate of swallowing function treatment

The effective rate was calculated according to the score of the standard swallowing function evaluation,scale, and the effective criterion was as follows: the patient's score increased by more than 30% > compared with that before treatment.

Time required for swallowing to improve

it will be assessed by Water Swallow Test (WST),this test divided into 1 ~ 5 levels. The higher level means less dysphagia

Full Information

NCT ID

NCT04398355

First Posted

April 24, 2020

Last Updated

March 23, 2022

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04398355

Brief Title

A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke

Official Title

A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 25, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The traditional Chinese medicine rehabilitation for post-stroke dysphagia impairment will be intervened, which can promote the recovery of dysphagia function of stroke patients, reduce the disability rate and improve the quality of life.

Detailed Description

This study will collect inpatients from April 2020 to December 2022 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

stroke, dysphagia, rehabilitation, traditional Chinese medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

basic treatment+Swallowing rehabilitation training

Arm Title

Combination treatment

Arm Type

Experimental

Arm Description

basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation

Arm Title

Liu-Zi-Jue treatment

Arm Type

Experimental

Arm Description

basic treatment+Swallowing rehabilitation training+Liu-Zi-Jue

Arm Title

acupuncture treatment

Arm Type

Experimental

Arm Description

basic treatment+Swallowing rehabilitation training+acupuncture

Intervention Type

Combination Product

Intervention Name(s)

acupuncture

Intervention Description

acupuncture

Intervention Type

Combination Product

Intervention Name(s)

Liu-Zi-Jue Gongfa

Intervention Description

Liu-Zi-Jue Gongfa

Primary Outcome Measure Information:

Title

Standardized Swallowing Assessment

Description

use Standardized Swallowing Assessment to evaluate the patient's conscious, lip closure control ability, the head and trunk control ability, the respiratory mode.

Time Frame

Change from Baseline Standardized Swallowing Assessment at 4 weeks

Secondary Outcome Measure Information:

Title

video fluoroscopic swallowing study score，VFSS score

Description

Time Frame

0 week；4 weeks

Title

The effective rate of swallowing function treatment

Description

Time Frame

at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks

Title

Time required for swallowing to improve

Description

it will be assessed by Water Swallow Test (WST),this test divided into 1 ~ 5 levels. The higher level means less dysphagia

Time Frame

at 0 week, 4 weeks, 8 weeks, 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Dysphagia Meet the diagnostic criteria of stroke in traditional Chinese medicine; Meet the diagnostic criteria of ischemic stroke in western medicine; meet the diagnostic criteria of pseudobulbar palsy; Age is 18-85, gender not limited; The course of disease is 30 to 180 days; Water test level 3 and level 3 above; Meet the requirements for indications of acupuncture and moxibustion techniques; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance; Sign informed consent MOCA（Montreal Cognitive Assessment） score above 15. Exclusion Criteria: Dysphagia Patients with true bulbar palsy caused by brainstem encephalitis, motor neurone disease, pontine tumor, multiple sclerosis, myasthenia gravis, medulla bulbar cavity; Cerebral hemorrhage caused by cerebrovascular malformation, trauma, aneurysm and other causes; Pregnant or lactating women; Patients with severe primary chronic diseases, severe dementia and cognitive impairment, serious language understanding disorders, and mental illness, including heart, liver, kidney and other viscera, as well as the endocrine system and hematopoietic system; Suffered from a variety of bleeding tendency diseases; The patient to swallow contrast drug allergy; Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, cannot judge the efficacy or incomplete data affect the judgment of efficacy and are not suitable for clinical observation;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

XINYUN LI, Doctor

Phone

+8618069783240

lxyjasmine2010@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RUIJIE MA, Doctor

Organizational Affiliation

The Third Affiliated hospital of Zhejiang Chinese Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

XINYUN LI, Master

Organizational Affiliation

Zhejiang Chinese Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Third Affiliated Hospital of Zhejiang Chinese Medical University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruijie Ma, Doctor

Phone

+86 18057102851

maria7878@sina.com

First Name & Middle Initial & Last Name & Degree

Xinyun Li, Master

Phone

+86 18069783240

First Name & Middle Initial & Last Name & Degree

Kelin He, Master

First Name & Middle Initial & Last Name & Degree

Siwen Li, Master

Facility Name

Hangzhou hospital of traditional Chinese medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liping LI, Doctor

Phone

+86 13857161334

First Name & Middle Initial & Last Name & Degree

Liping LI, Doctor

Facility Name

Jiaxing hospital of Chinese traditional medicine

City

Jiaxing

State/Province

Zhejiang

ZIP/Postal Code

314000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaitao LUO, Master

Phone

+86 13758395805

First Name & Middle Initial & Last Name & Degree

Kaitao LUO, Master

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke

We'll reach out to this number within 24 hrs