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NCT Number: NCT07620210

Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults

This study aims to investigate the effectiveness of resistance swallowing rehabilitation using Chin Tuck Against Resistance (CTAR) exercises combined with an innovative swallowing pressure ball in improving swallowing function and swallowing-related quality of life among home-based older stroke patients with dysphagia.

Participants will receive a 12-week swallowing rehabilitation program conducted in the home-care setting. Outcome measures include swallowing function assessments, swallowing-related quality of life, and rehabilitation adherence. The study is designed as a randomized controlled trial to explore the feasibility and clinical benefits of resistance-based swallowing rehabilitation in community and home-care environments.

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Key information

Conditions

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 Post-stroke Dysphagia Vascular Diseases

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ChiMei Medical Center

Tainan, Tainan City, 71004, Taiwan

Location status: Recruiting

Location contact

NAI CHING Chen, RN

PRINCIPAL_INVESTIGATOR

nai ching Chen, RN

CONTACT

[email protected]

+886 988031533

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 65 and 90 years.
  • Diagnosed with ischemic or hemorrhagic stroke more than 6 months prior to enrollment.
  • Receiving home care services from participating home care agencies.
  • Able to follow instructions and participate in swallowing training.
  • MMSE score ≥24, or adjusted according to education level.
  • Passed the second stage of the 3-step swallowing screening test.
  • Presence of post-stroke dysphagia symptoms.

Exclusion criteria

  • History of head and neck cancer or head and neck radiotherapy.
  • History of cervical spine surgery or tracheostomy.
  • Severe neurological or neuromuscular diseases affecting swallowing function.
  • Severe unstable medical conditions.
  • Current use of medications significantly affecting swallowing function or muscle tone.
  • Unable to complete the intervention or follow-up assessments.
  • Receiving tube feeding without oral intake ability.

Treatment and study plan

Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training

Device

Participants receive Chin Tuck Against Resistance (CTAR) swallowing training combined with an innovative swallowing pressure measurement ball intervention twice daily for 12 weeks.

Conventional Swallowing Rehabilitation

Behavioral

Participants receive conventional swallowing rehabilitation including tongue resistance exercise and oral motor control training.

Primary outcomes

  1. Swallowing Quality of Life Questionnaire (SWAL-QOL) Total Score

    Time frame: Baseline to Week 12

    Swallowing-related quality of life assessed using the Swallowing Quality of Life Questionnaire (SWAL-QOL). The total score ranges from 44 to 220 points, with higher scores indicating better swallowing-related quality of life.

Secondary outcomes

  1. GOKURI Swallowing Function and Cough Events

    Time frame: Baseline to Week 12

    Swallowing function assessed using the GOKURI wearable swallowing monitoring system. Outcomes include the frequency of cough events and swallowing-related acoustic signals. Lower cough event frequency indicates better swallowing safety and function.

Study contacts

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

nai ching Chen, RN

CONTACT

[email protected]

+886 988031533

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Registry information

Official study title

Effectiveness of Combining Chin Tuck Against Resistance Swallowing Training and an Innovative Swallowing Pressure Measurement Ball on the Swallowing Function and Quality of Life in Home-Based Older Adults With Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 3, 2026

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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