Dysphagia Following Cerebrovascular AccidentNCT05758350
Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia
A study testing home based IOPI swallow training in people with Dysphagia Following Cerebrovascular Accident, run by Taichung Veterans General Hospital.
Trial summary
Dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. Among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Dysphagia Following Cerebrovascular Accident
- What is being tested?
- home based IOPI swallow training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities
- Mini-Mental Status Examination >20, could cooperate swallow therapy
Who cannot join
- Already known dysphagia before stroke event
- Malocclusion or severe facial palsy
- Localized oral lesion interfering swallowing
Trial locations and contacts
No sites are listed yet.
About this study
Dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. Among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. Iowa oral performance instrument (IOPI) is a standardized portable device that can be used to quantify tongue muscle strength, thus allowing the clinician to set the level of resistance necessary to achieve optimal gains in strength, and also providing visual feedback of performance to the patients to guide training. In this study, we use Videofluoroscopic Swallowing Study (VFSS) to screen for the stroke patient suffering from dysphagia and recruited them into the trial. They then participated in a home based resistance-training program using the tongue depressor, 1 time everyday and each time consisted of 30 repetitions, totally 4 weeks. Various tongue strength variables and subjective scale were obtained before and after the intervention. The purpose of the study was to evaluate the effect of the home based swallowing therapy in the post stroke dysphagia patients.
- Being tested
- home based IOPI swallow training
- Keywords
- dysphagia, ischemic stroke, intracranial hemorrhage
- Medical subject headings
- Deglutition Disorders, Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home based IOPI swallow trainingBehavioural
Use IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group.
| Study group | Role | What they receive |
|---|---|---|
| Iowa Oral Performance Instrument (IOPI) training group | Experimental | Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) and home- IOPI based resistance training Receives: Behavioral: home based IOPI swallow training |
| controlled group | No intervention | Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior tongue pressure
Measured: 1 week after treatment
Posterior tongue pressure
Measured: 1 week after treatment
Right buccal pressure
Measured: 1 week after treatment
Left buccal pressure
Measured: 1 week after treatment
Labial pressure
Measured: 1 week after treatment
Secondary outcomes (1)
The score of Eat-10 scale
Measured: 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dysphagia Following Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758350
- Sponsor's protocol ID
- CF22483A
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JH, Kim HS, Yun DH, Chon J, Han YJ, Yoo SD, Kim DH, Lee SA, Joo HI, Park JS, Kim JC, Soh Y. The Relationship Between Tongue Pressure and Oral Dysphagia in Stroke Patients. Ann Rehabil Med. 2016 Aug;40(4):620-8. doi: 10.5535/arm.2016.40.4.620. Epub 2016 Aug 24.
PubMed 27606268Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.
PubMed 26834320Park HS, Oh DH, Yoon T, Park JS. Effect of effortful swallowing training on tongue strength and oropharyngeal swallowing function in stroke patients with dysphagia: a double-blind, randomized controlled trial. Int J Lang Commun Disord. 2019 May;54(3):479-484. doi: 10.1111/1460-6984.12453. Epub 2019 Jan 28.
PubMed 30693627Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.
PubMed 27883209
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT05758350
- Acronym / sponsor ID
- CF22483A
- Keywords
- dysphagia, ischemic stroke, intracranial hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 7 Mar 2023 (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.
Dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. Among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. Iowa oral performance instrument (IOPI) is a standardized portable device that can be used to quantify tongue muscle strength, thus allowing the clinician to set the level of resistance necessary to achieve optimal gains in strength, and also providing visual feedback of performance to the patients to guide training. In this study, we use Videofluoroscopic Swallowing Study (VFSS) to screen for the stroke patient suffering from dysphagia and recruited them into the trial. They then participated in a home based resistance-training program using the tongue depressor, 1 time everyday and each time consisted of 30 repetitions, totally 4 weeks. Various tongue strength variables and subjective scale were obtained before and after the intervention. The purpose of the study was to evaluate the effect of the home based swallowing therapy in the post stroke dysphagia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iowa Oral Performance Instrument (IOPI) training group | Experimental | Behavioral: home based IOPI swallow trainingIncluding conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) and home- IOPI based resistance training |
| controlled group | No intervention | –Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) only |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities
- Mini-Mental Status Examination >20, could cooperate swallow therapy
Key exclusion criteria (3 listed)
- Already known dysphagia before stroke event
- Malocclusion or severe facial palsy
- Localized oral lesion interfering swallowing
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 |
|---|---|---|
| home based IOPI swallow trainingUse IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group. | Behavioural | Iowa Oral Performance Instrument (IOPI) training group |
Primary outcome
Anterior tongue pressure
Time frame: 1 week after treatment
Posterior tongue pressure
Time frame: 1 week after treatment
Right buccal pressure
Time frame: 1 week after treatment
Left buccal pressure
Time frame: 1 week after treatment
Labial pressure
Time frame: 1 week after treatment
1 secondary outcome
The score of Eat-10 scale
Time frame: 1 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 27606268Lee JH, Kim HS, Yun DH, Chon J, Han YJ, Yoo SD, Kim DH, Lee SA, Joo HI, Park JS, Kim JC, Soh Y. The Relationship Between Tongue Pressure and Oral Dysphagia in Stroke Patients. Ann Rehabil Med. 2016 Aug;40(4):620-8. doi: 10.5535/arm.2016.40.4.620. Epub 2016 Aug 24.
- Background: PubMed 26834320Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.
- Background: PubMed 30693627Park HS, Oh DH, Yoon T, Park JS. Effect of effortful swallowing training on tongue strength and oropharyngeal swallowing function in stroke patients with dysphagia: a double-blind, randomized controlled trial. Int J Lang Commun Disord. 2019 May;54(3):479-484. doi: 10.1111/1460-6984.12453. Epub 2019 Jan 28.
- Results publication: PubMed 27883209Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing home based IOPI swallow training in people with Dysphagia Following Cerebrovascular Accident, run by Taichung Veterans General Hospital.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHUN MING FU ((886)04-2359-2525 ext. 3535, jimmyrehab@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior tongue pressure (time frame: 1 week after treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758350, which also lists 4 linked publications.
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 7 Mar 2023.