Effects of Chin Tuck Against Resistance Exercise on Patients With Dysphagia After Stroke

August 25, 2023 updated by: Chia-Chi Kuo, Chang Gung University of Science and Technology

Effects of Chin Tuck Against Resistance Exercise on Patients With Dysphagia After Stroke: A Randomized Controlled Trial

The aim of this clinical trial is to explore the effects of chin tuck against resistance (CTAR) exercises on improving dysphagia in stroke patients.

The main aims of this research are:

  1. To explore the effects of CTAR exercise on stroke patients with dysphagia, and to perform a clinically implementable evidence-based protocol.
  2. Introduce the evidence-based "CTAR exercise protocol" in the care of stroke patients with dysphagia, and test the effects through a randomized controlled trial.

This study is a two-group, pre and post-test, parallel, non-blind randomized controlled trial to test the effectiveness of the "CTAR exercise protocol". Convenience sampling the inpatients of stroke with dysphagia from a regional hospital in southern Taiwan. Eighty participants will be randomized block assignment either to an experimental (n = 40) or to a control (n = 40) group. The experimental group will receive a four-week CTAR protocol and regular dysphagia care. The control group will receive the regular dysphagia care only. In this study, dysphagia-related physiological indicators including functional oral intake scale (FOIS), penetration-aspiration scale (PAS), and modified water swallowing test, video fluoroscopic swallowing study (VFSS), and swallowing improvement rate will be used to evaluate the difference between pre-test and four-week post-test after the intervention. The independent t-test will be used to compare the change effect of the two groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a two-group, pre- and post-test, parallel, non-blind randomized controlled trial to test the effectiveness of the "chin retraction resistance exercise program". The convenient sampling will be used to select inpatients with stroke and dysphagia in a regional hospital from southern Taiwan. In this study, the investigators will use block randomization to assign participants to either experimental or control group, and use sealed opaque envelopes to conceal the allocation sequences. The target sample size of 80 participants will be enrolled according to sample size calculation. The CTAR exercise is to tighten a rubber ball which placed between the chin and the sternum, and to perform 3 cycles of isometric exercise and isotonic exercise. The CTAR protocol is perform CTAR exercises three times a day, five days a week, and for four weeks. The research nurses will assist in screen and recruit subjects in clinical ward units, perform the CTAR exercise protocol, and collect dates. The independent t-test will be used to compare the change effect of the two groups.

Study Type

Interventional

Enrollment (Estimated)

80

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inpatients with newly diagnosed stroke with dysphagia.
  • The modified water swallowing test shows that ≦ 4 points, which mean patient have a high risk of swallowing disorders.
  • Adults over 20 years old, without visual, hearing and mental disabilities.
  • Patients who have clear consciousness and can sit up at least 10 minutes to cooperate with swallowing training.

Exclusion Criteria:

  • In addition to not meeting the above selection criteria, those who have head and neck cancer or movement disorders and cannot cooperate with the chin tuck against resistance exercise will be listed as excluded cases.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
The experimental group will receive a four-week "CTAR exercise protocol " and routine dysphagia care.
Other: Chin tuck against resistance exercise
The experimental group will receive a four-week CTAR protocol and regular dysphagia care, while the control group will only receive routine dysphagia care. The routine dysphagia care is including dysphagia education, dietary precautions, oral hygiene, and swallowing training, etc. The CTAR protocol is first, the study nurses face-to-face teach dysphagia patients to perform CTAR exercises once, then the patient perform CTAR exercises three times a day, five days a week, and for four weeks. The CTAR exercise is to tighten a rubber ball which placed between the chin and the sternum, and to perform 3 cycles of isometric exercise and isotonic exercise.
Other Names:
  • Routine dysphagia care
No Intervention: control group
The control group will only receive routine dysphagia care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
video fluoroscopic swallowing study (VFSS)
Time Frame: Pre-test and four-week post-test
The video fluoroscopic swallowing study (VFSS) is a routine clinical swallowing photography examination to diagnosis the dysphagia problems and severity, which is perform and report by radiologist. The radiologist will interpret the image and report the swallowing function of VFSS as normal, penetration, or aspiration. The research nurse will collect the data of swallowing function on the existing VFSS reports of the electronic medical records. The collected measurement data will be aggregated on an excel dataset.photography examination, and the research nurse will collect the existing VFSS report on the electronic medical records.
Pre-test and four-week post-test
The functional oral intake scale: One question, 1~7 scores.
Time Frame: Pre-test and four-week post-test
The functional oral intake scale (FOIS) is a 7-point scale, which is used to measure the state of eating by mouth. A score of 1 means that patient can't eat by mouth at all, and a score of 7 means patient can eat food of any stickiness and type by mouth. The research nurse will use this scale to test the state of eating by mouth of participants, and collect the pre-test and four-week post-test data then record on an excel dataset.
Pre-test and four-week post-test
The penetration-aspiration scale: One question, 1~8 scores.
Time Frame: Pre-test and four-week post-test
The penetration-aspiration scale (PAS) is an 8-point scale used to measure laryngeal leakage and aspiration severity, which with higher scores representing more severe respiratory aspiration. A score of 1 means that normal swallowing function, and a score of 8 means food mistakenly enters airway and without cough re¬flex during swallowing. The research nurse will use this scale to test the laryngeal leakage and aspiration severity of participants, and collect the pre-test and four-week post-test data then record on an excel dataset.
Pre-test and four-week post-test
The modified water swallowing test : One question, 1~5 scores.
Time Frame: Pre-test and four-week post-test
The modified water swallowing test (MWST) is a 1 to 5-point scale, which is a routine used clinical swallowing test. The researcher nurse will inject 3ml of cold water into the bottom of the participant's mouth with an injection syringe, and then asks the participant to swallow the water for the swallowing test. If the participant is unable to swallow, or experienced dyspnea, coughing, or wet-hoarse dysphonia after swallowing, a score of 1-3 will be respective recorded. The lower the score, meaning the more serious problem of swallowing and choking. The sensitivity and specificity of MWST to differentiate between aspirators and non-aspirators with a cutoff level of 3 are 70 and 88%, respectively. The research nurse will use this scale to test the water swallowing function of participants for a screen scale of inclusion criteria, and collect the pre-test and four-week post-test data then record on an excel dataset.
Pre-test and four-week post-test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The swallowing improvement rate: Number of participants with swallowing improvement event as assessed by the modified water swallowing test.
Time Frame: Four-week post-test
Based on the pre- and post-test scores of the modified water drinking test, the researcher will calculate the number of participants who have present improved at post-test scores, and then calculate the swallowing improvement rates of the two groups. The formula is: The swallowing improvement rate= Number of participants with improve events (modified water swallowing test showed the post-test score is improve compare to pre-test) ÷ number of participants of each group × 100%.
Four-week post-test

Collaborators and Investigators

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

Sponsor

Chang Gung University of Science and Technology

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YUAN20230103B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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