Clinical trial NCT05758350: Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia
Official title: Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia Following Cerebrovascular Accident
Keywords: dysphagia
ischemic stroke
intracranial hemorrhage
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities
* Mini-Mental Status Examination \>20, could cooperate swallow therapy

Exclusion Criteria:

* Already known dysphagia before stroke event
* Malocclusion or severe facial palsy
* Localized oral lesion interfering swallowing

Primary outcomes:
measure: Anterior tongue pressure
timeFrame: 1 week after treatment
measure: Posterior tongue pressure
timeFrame: 1 week after treatment
measure: Right buccal pressure
timeFrame: 1 week after treatment
measure: Left buccal pressure
timeFrame: 1 week after treatment
measure: Labial pressure
timeFrame: 1 week after treatment
Secondary outcomes:
measure: The score of Eat-10 scale
timeFrame: 1 week after treatment
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Park 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.
citation: Park 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.
citation: Kim 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.