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NCT Number: NCT06674356

The Effects of Chin Tuck Against Resistance Exercise on 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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nursing, National Taiwan University

Taipei, Taiwan

Location status: Recruiting

Location contact

Fang-Ju Lin

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

chin tuck against resistance exercise

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.

Other names: Traditional swallowing rehabilitation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang-Ju Lin

CONTACT

[email protected]

+886-23123456 ext. 262788

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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