Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

NCT ID: NCT05758350

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia Following Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Iowa Oral Performance Instrument (IOPI) training group

Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) and home- IOPI based resistance training

Group Type EXPERIMENTAL

home based IOPI swallow training

Intervention Type BEHAVIORAL

Use IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group.

controlled group

Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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home based IOPI swallow training

Use IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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CHUN MING FU

Role: CONTACT

(886)04-2359-2525 ext. 3535

References

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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.

Reference Type BACKGROUND
PMID: 27606268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26834320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30693627 (View on PubMed)

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.

Reference Type RESULT
PMID: 27883209 (View on PubMed)

Other Identifiers

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CF22483A

Identifier Type: -

Identifier Source: org_study_id

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