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

NCT ID: NCT06674356

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-22
• Study Completion Date: 2027-10-31

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.

Conditions

Acute Stroke; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Experimental Group:Participants in this group will receive traditional swallowing rehabilitation combined with chin tuck against resistance (CTAR) training to enhance suprahyoid muscle strength and improve swallowing function.

Group Type: EXPERIMENTAL

chin tuck against resistance exercise

Intervention Type: BEHAVIORAL

Both groups of patients will receive traditional swallowing rehabilitation therapy; however, the experimental group will additionally perform CTAR exercises. The procedure is as follows:Ask the patient to sit, then, press the chin firmly against the inflatable rubber ball, for isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. And for isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions. Performing both isometric and isotonic exercises constitutes one set of exercises.

For isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. For isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions.

Control Group

Control Group:Participants in this group will receive only traditional swallowing rehabilitation without any additional CTAR training.

Group Type: PLACEBO_COMPARATOR

chin tuck against resistance exercise

Intervention Type: BEHAVIORAL

Both groups of patients will receive traditional swallowing rehabilitation therapy; however, the experimental group will additionally perform CTAR exercises. The procedure is as follows:Ask the patient to sit, then, press the chin firmly against the inflatable rubber ball, for isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. And for isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions. Performing both isometric and isotonic exercises constitutes one set of exercises.

For isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. For isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions.

Interventions

chin tuck against resistance exercise

Both groups of patients will receive traditional swallowing rehabilitation therapy; however, the experimental group will additionally perform CTAR exercises. The procedure is as follows:Ask the patient to sit, then, press the chin firmly against the inflatable rubber ball, for isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. And for isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions. Performing both isometric and isotonic exercises constitutes one set of exercises.

For isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. For isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions.

Intervention Type: BEHAVIORAL

Other Intervention Names

Traditional swallowing rehabilitation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Nursing, National Taiwan University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Fang-Ju Lin

Role: CONTACT

linfunzoe@ntuh.gov.tw

+886-23123456 ext. 262788

Facility Contacts

Fang-Ju Lin

Role: primary

Other Identifiers

202408146RINB

Identifier Type: -

Identifier Source: org_study_id