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

May 8, 2025 updated by: National Taiwan University Hospital

The Effects of Chin Tuck Against Resistance Exercise on Swallowing Function, Depression, and Quality of Life in Acute Stroke Patients With Dysphagia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Department of Nursing, National Taiwan University
        • Contact:
          • Fang-Ju Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

Other Names:
  • Traditional swallowing rehabilitation
Placebo Comparator: Control Group
Control Group:Participants in this group will receive only traditional swallowing rehabilitation without any additional CTAR training.
Behavioral: 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.

Other Names:
  • Traditional swallowing rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
swallowing function
Time Frame: 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.
before intervention and up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 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.
before intervention and up to 6 and 10 weeks
Swallowing-Related Quality of Life
Time Frame: 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.
before intervention and up to 6 and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202408146RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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