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Efficacy and safety of acupuncture for dysphagia in the acute stage of stroke: a multicenter randomized sham-controlled trial

Not Applicable
Recruiting
Conditions
Dysphagia after Stroke
Registration Number
ITMCTR1900002821
Lead Sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. The patient meets the diagnostic criteria of acute stroke in Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018 and the diagnostic criteria of dysphagia in Scotch College's Guide for dysphagia.
2. 3 days (72 hours) <= Course of disease <= 7 days;
3. FOIS score ranged 2 to 4;
4. The patients present with pharyngeal symptoms, including delayed swallowing, or decreased oral volume, or chocking and coughing;
5. Aged 40 to 80 years;
6. Informed consent signed voluntarily by the patient or legal representative.

Exclusion Criteria

1. The patient with dysphagia before the onset of the disease;
2. The patients were expected to survive for less than 3 months;
3. The patient with medulla oblongata infarction;
4. The patient with consciousness disorder;
5. The patient unable to complete the study due to mental disorders and cognitive impairment (mini-cog < 3 points);
6. The patient unable to tolerate acupuncture;
7. A woman who is pregnant, planning to be pregnant, or breastfeeding;
8. The patient had received thrombolytic therapy after the onset of the disease;
9. Participants in other clinical trials in the past 1 month.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Functional Oral Intake Scale;
Secondary Outcome Measures
NameTimeMethod
nutrition risk screening;Swallowing Quality of Life Questionnaire;the Volume-viscosity swallow test;Water Swallow Test;Patient Reported Outcome;National Institute of Health stroke scale;Standardized Swallowing Assessment;Incidence of Pneumonia;Results of Fberoptic Endoscopic Evaluation of Swallowing;
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