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

NCT06013267 | Unknown

• 1 other identifier: YUAN20230103B
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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:

1. 1.To explore the effects of CTAR exercise on stroke patients with dysphagia, and to perform a clinically implementable evidence-based protocol.
2. 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.

Conditions

Stroke

Keywords

stroke; dysphagia; chin tuck against resistance exercise; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• 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.

  Pre-test and four-week post-test

• 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.

  Pre-test and four-week post-test

• 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.

  Pre-test and four-week post-test

• 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.

  Pre-test and four-week post-test

Secondary Outcomes (1)

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

  Four-week post-test

Study Arms (2)

experimental group

EXPERIMENTAL

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

Other: Chin tuck against resistance exercise

control group

NO INTERVENTION

The control group will only receive routine dysphagia care.

Interventions

Chin tuck against resistance exercise OTHER

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.

Also known as: Routine dysphagia care

experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead

Related Publications (8)

• 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.

  PMID: 27830923 BACKGROUND

• 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.

  PMID: 31206210 BACKGROUND

• 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.

  PMID: 33530263 BACKGROUND

• 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.

  PMID: 34746431 BACKGROUND

• 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.

  PMID: 16084801 BACKGROUND

• 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.

  PMID: 29562558 BACKGROUND

• 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.

  PMID: 31515567 BACKGROUND

• 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.

  PMID: 31662037 BACKGROUND

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Chia-Chi Kuo, Associate Professor

CONTACT

+886-5-3628800; cckuo@mail.cgust.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 28, 2023
• Study Start: September 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share