Clinical trial NCT06013267: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
dysphagia
chin tuck against resistance exercise
randomized controlled trial
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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.

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.

Primary outcomes:
measure: The functional oral intake scale: One question, 1~7 scores.
timeFrame: Pre-test and four-week post-test
measure: The penetration-aspiration scale: One question, 1~8 scores.
timeFrame: Pre-test and four-week post-test
measure: The modified water swallowing test : One question, 1~5 scores.
timeFrame: Pre-test and four-week post-test
measure: video fluoroscopic swallowing study (VFSS)
timeFrame: Pre-test and four-week post-test
Secondary outcomes:
measure: The swallowing improvement rate: Number of participants with swallowing improvement event as assessed by the modified water swallowing test.
timeFrame: Four-week post-test
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.