Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

March 5, 2023 updated by: Taichung Veterans General Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: home based IOPI swallow training
Use IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group.
No Intervention: controlled group
Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anterior tongue pressure
Time Frame: 1 week after treatment
1 week after treatment
Posterior tongue pressure
Time Frame: 1 week after treatment
1 week after treatment
Right buccal pressure
Time Frame: 1 week after treatment
1 week after treatment
Left buccal pressure
Time Frame: 1 week after treatment
1 week after treatment
Labial pressure
Time Frame: 1 week after treatment
1 week after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The score of Eat-10 scale
Time Frame: 1 week after treatment
1 week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2023

Primary Completion (Anticipated)

May 30, 2024

Study Completion (Anticipated)

May 30, 2024

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF22483A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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