Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-08-17
Brief Title:
Effects of Chin Tuck Against Resistance Exercise on Patients With Dysphagia After Stroke
Sponsor:
Chang Gung University of Science and Technology
Organization:
Chang Gung University of Science and Technology
Study Overview
Official Title:
Effects of Chin Tuck Against Resistance Exercise on Patients With Dysphagia After Stroke A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None