Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorChimei Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training
DeviceParticipants 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
BehavioralParticipants receive conventional swallowing rehabilitation including tongue resistance exercise and oral motor control training.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: CTAR Combined With Innovative Swallowing Pressure BallExperimental treatment 1 intervention
Group B: Conventional Swallowing RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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.
Time frame
Baseline to Week 12Sponsors and contacts
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Source ClinicalTrials.gov