Dysphagia, Post-Stroke Dysphagia, Stroke
Conditions
Keywords
CTAR, Swallowing Rehabilitation, Swallowing Pressure Ball, Home Care, Older Adults, Stroke Rehabilitation
Brief summary
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
DEVICEInnovative 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.
BEHAVIORALConventional Swallowing Rehabilitation
Participants receive conventional swallowing rehabilitation including tongue resistance exercise and oral motor control training.
Sponsors
Chimei Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be assigned to either the intervention group or control group using a parallel-group cluster-randomized design conducted in home-care settings.
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing Quality of Life Questionnaire (SWAL-QOL) Total Score | 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
| Measure | Time frame | Description |
|---|---|---|
| GOKURI Swallowing Function and Cough Events | 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. |
Countries
Taiwan
Contacts
CONTACTnai ching Chen, RN
Outcome results
None listed