The Effects of Chin Tuck Against Resistance Exercise on Acute Stroke Patients With Dysphagia

Not Applicable

Recruiting

• Conditions: Acute Stroke; Dysphagia

• Registration Number: NCT06674356
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The aim of this study is to investigate the effects of chin tuck against resistance exercise on swallowing function, depression, and quality of life in acute stroke patients with dysphagia.

Detailed Description

The study is an experimental research design, with participants randomly assigned to either the experimental group or the control group. The experimental group will undergo chin tuck against resistance exercises, while the control group will receive traditional swallowing rehabilitation training. The subjects of this study are patients from the neurology and rehabilitation wards of a medical center in northern Taiwan. The research tools include a personal basic information questionnaire, the standardized swallowing assessment, the Functional Oral Intake Scale, the Patient Health Questionnaire-9, and the Taiwan version of the Swallowing Quality of Life Questionnaire. Data collection for both groups will be conducted using a pre-test and post-test method.

Study Timeline

• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2024-11-03
• Study First Posted: 2024-11-05
• Study Start: 2024-12-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Patients diagnosed with hemorrhagic or ischemic stroke, including those with initial diagnoses or recurrent strokes.
2. Patients who did not pass the swallowing screening based on the standard swallowing scale.
3. Adults aged 18 years and older.
4. Vital signs are stable: systolic blood pressure (hemorrhagic < 160 mmHg, ischemic < 220 mmHg), heart rate 40-130 beats per minute, and oxygen saturation > 92%.
5. The patient's consciousness is clear, able to express themselves, can communicate in Mandarin or Taiwanese, and can follow commands to perform actions.
6. The patient can be in a seated position.

Exclusion Criteria

1. Patients who have had a stroke for more than one month (inclusive).
2. Patients with a history of depression or related mental health disorders.
3. Patients with a history of neck pain, injury, or disease.
4. Patients who have previously undergone tracheostomy or have a tracheostomy tube in place.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
swallowing function	before intervention and up to 6 weeks	Use the Functional Oral Intake Scale(FOIS) 、calculating the residual volume of 60 ml of water, swallowing speed, and whether a nasogastric tube is in place to assess swallowing function. FOIS items range from 1 to 7，the higer the better swallowing function。The less residual water and fast swallowing speed(ml/sec), the better the swallowing function. The absence of a nasogastric tube also indicates improvement in swallowing.

Secondary Outcome Measures

Name	Time	Method
Depression	before intervention and up to 6 and 10 weeks	Use the Patient Health Questionnaire(PHQ-9) to assess depression，the score ranges from 0 to 27 points: 0-4 indicates no depressive symptoms, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression.
Swallowing-Related Quality of Life	before intervention and up to 6 and 10 weeks	use the Taiwanese version of the Swallowing Quality of Life Questionnaire to evaluate quality of Life. The questionnaire consists of 44 questions, scored on a 5-point Likert scale. Each question has a maximum score of 5 and a minimum score of 1. Higher scores on the questionnaire indicate a better quality of life.

Trial Locations

Locations (1)

Department of Nursing, National Taiwan University; 🇨🇳 Taipei, Taiwan