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

N/ARecruitingNCT07620210

Chimei Medical Center132 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Stroke Dysphagia Post-Stroke Dysphagia

Interventions

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline to Week 12

Secondary Outcomes

GOKURI Swallowing Function and Cough Events

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.