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

NCT06674356 | Recruiting

• 1 other identifier: 202408146RINB
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke; Dysphagia

Outcome Measures

Primary Outcomes (1)

• swallowing function

  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 Outcomes (2)

• Depression

  before intervention and up to 6 and 10 weeks

• Swallowing-Related Quality of Life

  before intervention and up to 6 and 10 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Behavioral: chin tuck against resistance exercise

Interventions

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.

Also known as: Traditional swallowing rehabilitation

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Nursing, National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Fang-Ju Lin

CONTACT

+886-23123456; linfunzoe@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: December 22, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)