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Recruiting NCT07620210

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

No phase Interventional Stroke Dysphagia Post-Stroke Dysphagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training, Conventional Swallowing Rehabilitation.
Who it may be relevant to
Registry conditions: Stroke, Dysphagia, Post-Stroke Dysphagia. Basic parameters: 65 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Device Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training
    Participants receive Chin Tuck Against Resistance (CTAR) swallowing training combined with an innovative swallowing pressure measurement ball intervention twice daily for 12 weeks.
  • Behavioral Conventional Swallowing Rehabilitation
    Participants receive conventional swallowing rehabilitation including tongue resistance exercise and oral motor control training.

Primary outcome measures

  • Swallowing Quality of Life Questionnaire (SWAL-QOL) Total Score [Time frame: Baseline to Week 12]
Secondary outcome measures (1)
  • GOKURI Swallowing Function and Cough Events [Time frame: Baseline to Week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • ChiMei Medical Center — Tainan

Identifiers

NCT: NCT07620210 · CMMC11404013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗