NCT06013267

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chang Gung University of Science and Technology · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-08-28
• Last updated: 2023-08-29