StrokeNCT07620210
Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults
A study testing Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training and Conventional Swallowing Rehabilitation in people with Stroke and Dysphagia, run by Chimei Medical Center at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Stroke, Dysphagia, Post-Stroke Dysphagia
- What is being tested?
- Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training and Conventional Swallowing Rehabilitation
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
ChiMei Medical Center
Tainan, Tainan City, 71004
nai ching Chen, RN, +886 988031533, dreampatty11@gmail.com
NAI CHING Chen, RN
About this study
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
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.
- Conditions
- Stroke, Dysphagia, Post-Stroke Dysphagia
- Being tested
- Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training, Conventional Swallowing Rehabilitation
- Keywords
- CTAR, Swallowing Rehabilitation, Swallowing Pressure Ball, Home Care, Older Adults, Stroke Rehabilitation
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative Swallowing Pressure Measurement Ball Combined With CTAR TrainingDevice
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 RehabilitationBehavioural
Participants receive conventional swallowing rehabilitation including tongue resistance exercise and oral motor control training.
| Study group | Role | What they receive |
|---|---|---|
| CTAR Combined With Innovative Swallowing Pressure Ball | Experimental | Not described Receives: Device: Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training |
| Conventional Swallowing Rehabilitation | Active comparator | Not described Receives: Behavioral: Conventional Swallowing Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start18 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAI CHING CHEN, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620210
- Sponsor's protocol ID
- CMMC11404013
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07620210
- Acronym / sponsor ID
- CMMC11404013
- Conditions
- Stroke, Dysphagia, Post-Stroke Dysphagia
- Keywords
- CTAR, Swallowing Rehabilitation, Swallowing Pressure Ball, Home Care, Older Adults, Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CTAR Combined With Innovative Swallowing Pressure Ball | Experimental | Device: Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training |
| Conventional Swallowing Rehabilitation | Active comparator | Behavioral: Conventional Swallowing Rehabilitation |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innovative Swallowing Pressure Measurement Ball Combined With CTAR TrainingParticipants receive Chin Tuck Against Resistance (CTAR) swallowing training combined with an innovative swallowing pressure measurement ball intervention twice daily for 12 weeks. | Device | CTAR Combined With Innovative Swallowing Pressure Ball |
| Conventional Swallowing RehabilitationParticipants receive conventional swallowing rehabilitation including tongue resistance exercise and oral motor control training. | Behavioural | Conventional Swallowing Rehabilitation |
Primary outcome
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.
1 secondary outcome
GOKURI Swallowing Function and Cough Events
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training and Conventional Swallowing Rehabilitation in people with Stroke and Dysphagia, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact nai ching Chen, RN (+886 988031533, dreampatty11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing Quality of Life Questionnaire (SWAL-QOL) Total Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.