NCT07630116

Brief Summary

According to a 2014 report from the Ministry of Health and Welfare, cerebrovascular disease is one of the leading causes of death, with a mortality rate of 51.6 per 100,000 population, ranking fourth among the top ten causes of death. Stroke is often associated with symptoms such as unilateral weakness, slurred speech, facial asymmetry, and swallowing or speech difficulties, with approximately 42-67% of patients experiencing dysphagia. Dysphagia is primarily associated with dysfunction of the pharyngeal muscles and impaired coordination, often accompanied by central nervous system dysfunction. Common symptoms include choking, coughing after eating, drooling, difficulty eating, and swallowing problems, which may lead to complications such as pneumonia and malnutrition. Chin tuck against resistance (CTAR), developed by Yoon et al. in 2014, is a simple and non-invasive exercise aimed at improving pharyngeal muscle contraction, chewing and bolus formation, and coordination between the pharynx and upper esophagus. Previous studies suggest that CTAR exercises can effectively improve swallowing-related muscle function. However, there is a lack of research targeting acute stroke patients in hospital settings. Therefore, this study is designed as a randomized controlled trial (RCT) to evaluate the effectiveness of CTAR exercises in improving dysphagia. Participants will be randomly assigned to an experimental group or a control group. The experimental group will perform CTAR exercises once daily, five days per week, for two weeks, in addition to routine rehabilitation exercises until discharge. The control group will receive routine rehabilitation exercises once daily, five days per week. Effectiveness will be assessed using a 90 mL water swallowing test and the Eating Assessment Tool-10 (EAT-10). Baseline measurements will be conducted prior to the intervention, and subsequent assessments will be performed every two days during the study period. Additional outcomes include changes in EAT-10 scores and the removal rate of nasogastric tubes before discharge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Chin Tuck Against ResistanceStrokeDysphagia

Outcome Measures

Primary Outcomes (1)

  • Swallowing function assessed by 90 mL water swallowing test

    Swallowing function is evaluated using a 90 mL water swallowing test. Participants are assessed at baseline and every 2 days during the intervention period. The outcome is recorded as pass or fail to determine improvement in swallowing ability.

    Baseline and every 2 days during the 2-week intervention period

Secondary Outcomes (1)

  • Swallowing-related quality of life assessed by EAT-10

    Baseline and once weekly during the 2-week intervention period

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants receive routine rehabilitation plus chin tuck against resistance (CTAR) exercise.

Behavioral: Chin Tuck Against Resistance (CTAR)Other: Routine Rehabilitation

Control Group

ACTIVE COMPARATOR

Participants receive routine rehabilitation therapy only.

Other: Routine Rehabilitation

Interventions

Participants perform chin tuck against resistance (CTAR) exercise once daily, five days per week, for two consecutive weeks. The exercise is conducted in addition to routine rehabilitation therapy to improve swallowing function.

Experimental Group

Participants receive routine rehabilitation therapy once daily, five days per week, for two consecutive weeks.

Control GroupExperimental Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 20 years diagnosed with ischemic stroke
  • NIH Stroke Scale (NIHSS) score between 6 and 20
  • Conscious and able to communicate in Mandarin or Taiwanese
  • Failed the 90 mL water swallow test

You may not qualify if:

  • Cognitive impairment
  • Brainstem stroke or intracerebral hemorrhage
  • Diagnosed psychiatric disorder or dementia
  • Unstable vital signs
  • Presence of endotracheal tube or tracheostomy
  • History of cervical spine injury
  • Head-of-bed elevation restricted to less than 30 degrees
  • Nil per os (NPO) status as ordered by a physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Hsiao-Chi Nieh, Nursing Supervisor

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the rehabilitation intervention, participants and therapists are not blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

October 26, 2024

Primary Completion

April 20, 2026

Study Completion

April 23, 2026

Last Updated

June 5, 2026

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. The dataset contains sensitive clinical information, and sharing is restricted to protect participant identity in accordance with institutional policies and ethical regulations.

Locations