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Jin-San-Aupuncture exercise therapy in the treatment of dysphagia during convalescence after stroke

Registration number：

ITMCTR2024000056

Date of Last Refreshed on：

2024-05-06

Date of Registration：

2024-05-06

Registration Status：

Retrospective registration

Public title：

Jin-San-Aupuncture exercise therapy in the treatment of dysphagia during convalescence after stroke

English Acronym：

Scientific title：

A prospective randomized controlled study of Jin-San-Acupuncture exercise therapy in the treatment of dysphagia in convalescent period after stroke

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yihong LI

Study leader：

Chao Jia

Applicant telephone：

13533964388

Study leader's telephone：

13535307000

Applicant Fax：

Study leader's fax：

Applicant E-mail：

734543531@qq.com

Study leader's E-mail：

doctorjiachao@163.com

Study leader's website(voluntary supply)：

广州中医药大学

Study leader's website
(voluntary supply)：

Applicant address：

16th, Airport Road, Baiyun District, Guangzhou City, Guangdong Province, China

Study leader's address：

16th, Airport Road, Baiyun District, Guangzhou City, Guangdong Province, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangzhou University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

K-2023-186

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine

Date of approved by ethic committee：

2024/3/6 0:00:00

Contact Name of the ethic committee：

Xinying Li

Contact Address of the ethic committee：

gztcmlunli@163.com

Contact phone of the ethic committee：

020-36588667

Contact email of the ethic committee：

gztcmlunli@163.com

Primary sponsor：

Guangzhou University of Traditional Chinese Medicine

Primary sponsor's address：

16th, Airport Road, Baiyun District, Guangzhou City, Guangdong Province, China

Secondary sponsor：

Country：

中国

Province：

广东省

City：

Institution
hospital：

广州中医药大学

Address：

16th, Airport Road, Baiyun District, Guangzhou City, Guangdong Province, China

Source(s) of funding：

Guangdong Bureau of Traditional Chinese Medicine

Target disease：

Dysphagia during recovery from stroke

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

To verify the advantages of Jin San-acupuncture therapy in the treatment of dysphagia after stroke.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Meet the diagnostic criteria for stroke, and dysphagia is caused by stroke; 2. In the recovery period of stroke, the onset of the disease within 1 month to 6 months; 3. Potable Water Test (WST) is at grade 3-5; 4. Stable vital signs, no serious intellectual impairment or sensory aphasia affect the understanding of instructions, can understand and match The Mini-Mental State Examination (MMSE) was performed based on simple instructions from the therapist. Assessed as "no cognitive impairment"; 5. Good compliance, patients and their families are willing to cooperate with the treatment plan and follow-up of this study; 6. Study subjects and their families should fully understand the risks and benefits of treatment, voluntarily participate in the trial, and sign informed consent Books.

Exclusion criteria：

1. Combined with other diseases affecting the swallowing function, such as esophageal tumors, Guillain-Barre syndrome, head and neck tumors; Or combined with other conditions that affect the swallowing function, such as tracheotomy, the need to fast water due to illness; 2. Complicated with serious heart, lung, liver, kidney, tumor and other systemic diseases; Or patients with cachexia combined with abnormal coagulation function, hematological diseases or extreme wasting; 3. The number of strokes ≥2; 4. The expected survival time is less than 3 months; 5. Patients with existing or suspected aspiration pneumonia; 6. Pregnant or lactating women; 7. Participating in other clinical trials or having received other relevant acupuncture treatment may affect the investigator.

Study execute time：

From 2024-03-06

To      2025-12-31

Recruiting time：

From 2024-03-08

To      2025-10-01

Interventions：

53

Group：

3

Sample size：

Intervention：

创新靳三针同时康复训练

Intervention code：

53

Group：

2

Sample size：

Intervention：

创新靳三针穴组

Intervention code：

53

Group：

1

Sample size：

Intervention：

靳三针传统取穴组

Intervention code：

Total sample size ： 159

Countries of recruitment
and research settings：

Country：

中国

Province：

广东省

City：

广州

Institution/hospital：

广州中医药大学第一附属医院

Level of the institution：

省属

Outcomes：

Outcome：

Blood oxygen saturation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hyoid displacement amplitude

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

standardized swallowing assessment

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

water swallowing test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

the Short-Form Health Survey

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

无

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

30
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Data analysts use SPSS26.0 software to generate 159 random numbers from seed numbers, and press the generated random numbers 1:1:1 is divided into three groups, register random numbers and groups one by one, then put them into envelopes to seal, and write on the surface of the envelopes in turn 1-159 to the doctor. After the patients were enrolled, the physician opened the envelope according to the order in which the patients were nrolled The patients were divided into three groups: traditional point selection group, new addition group and exercise therapy group.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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