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

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chin tuck against resistance exercise
Sponsored by
Chang Gung University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, dysphagia, chin tuck against resistance exercise, randomized controlled trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental group

    control group

    Arm Description

    The experimental group will receive a four-week "CTAR exercise protocol " and routine dysphagia care.

    The control group will only receive routine dysphagia care.

    Outcomes

    Primary Outcome Measures

    The functional oral intake scale: One question, 1~7 scores.
    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.
    The penetration-aspiration scale: One question, 1~8 scores.
    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.
    The modified water swallowing test : One question, 1~5 scores.
    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.
    video fluoroscopic swallowing study (VFSS)
    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.

    Secondary Outcome Measures

    The swallowing improvement rate: Number of participants with swallowing improvement event as assessed by the modified water swallowing 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%.

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Chang Gung University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06013267
    Brief Title
    Effects of Chin Tuck Against Resistance Exercise on Patients With Dysphagia After Stroke
    Official Title
    Effects of Chin Tuck Against Resistance Exercise on Patients With Dysphagia After Stroke: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung University of Science and Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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: To explore the effects of CTAR exercise on stroke patients with dysphagia, and to perform a clinically implementable evidence-based protocol. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    stroke, dysphagia, chin tuck against resistance exercise, randomized controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive a four-week "CTAR exercise protocol " and routine dysphagia care.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The control group will only receive routine dysphagia care.
    Intervention Type
    Other
    Intervention Name(s)
    Chin tuck against resistance exercise
    Other Intervention Name(s)
    Routine dysphagia care
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The functional oral intake scale: One question, 1~7 scores.
    Description
    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.
    Time Frame
    Pre-test and four-week post-test
    Title
    The penetration-aspiration scale: One question, 1~8 scores.
    Description
    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.
    Time Frame
    Pre-test and four-week post-test
    Title
    The modified water swallowing test : One question, 1~5 scores.
    Description
    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.
    Time Frame
    Pre-test and four-week post-test
    Title
    video fluoroscopic swallowing study (VFSS)
    Description
    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.
    Time Frame
    Pre-test and four-week post-test
    Secondary Outcome Measure Information:
    Title
    The swallowing improvement rate: Number of participants with swallowing improvement event as assessed by the modified water swallowing test.
    Description
    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%.
    Time Frame
    Four-week post-test

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chia-Chi Kuo, Associate Professor
    Phone
    +886-5-3628800
    Ext
    2625
    Email
    cckuo@mail.cgust.edu.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27830923
    Citation
    Gao J, Zhang HJ. Effects of chin tuck against resistance exercise versus Shaker exercise on dysphagia and psychological state after cerebral infarction. Eur J Phys Rehabil Med. 2017 Jun;53(3):426-432. doi: 10.23736/S1973-9087.16.04346-X. Epub 2016 Nov 10.
    Results Reference
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    PubMed Identifier
    31206210
    Citation
    Kim HH, Park JS. Efficacy of modified chin tuck against resistance exercise using hand-free device for dysphagia in stroke survivors: A randomised controlled trial. J Oral Rehabil. 2019 Nov;46(11):1042-1046. doi: 10.1111/joor.12837. Epub 2019 Jul 2.
    Results Reference
    background
    PubMed Identifier
    33530263
    Citation
    Oguchi N, Yamamoto S, Terashima S, Arai R, Sato M, Ikegami S, Horiuchi H. The modified water swallowing test score is the best predictor of postoperative pneumonia following extubation in cardiovascular surgery: A retrospective cohort study. Medicine (Baltimore). 2021 Jan 29;100(4):e24478. doi: 10.1097/MD.0000000000024478.
    Results Reference
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    PubMed Identifier
    34746431
    Citation
    Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.
    Results Reference
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    PubMed Identifier
    16084801
    Citation
    Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20. doi: 10.1016/j.apmr.2004.11.049.
    Results Reference
    background
    PubMed Identifier
    29562558
    Citation
    Park JS, An DH, Oh DH, Chang MY. Effect of chin tuck against resistance exercise on patients with dysphagia following stroke: A randomized pilot study. NeuroRehabilitation. 2018;42(2):191-197. doi: 10.3233/NRE-172250.
    Results Reference
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    PubMed Identifier
    31515567
    Citation
    Park JS, Lee G, Jung YJ. Effects of game-based chin tuck against resistance exercise vs head-lift exercise in patients with dysphagia after stroke: An assessor-blind, randomized controlled trial. J Rehabil Med. 2019 Oct 29;51(10):749-754. doi: 10.2340/16501977-2603.
    Results Reference
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    Citation
    Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30. Erratum In: Stroke. 2019 Dec;50(12):e440-e441.
    Results Reference
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    Effects of Chin Tuck Against Resistance Exercise on Patients With Dysphagia After Stroke

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