Back to resultsInvestigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients
Primary Purpose
Stroke, Dysphagia, Swallowing Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Active Comparator: Routine Exercise Group
Experimental: PNF Exercise
Experimental: CTAR Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Dysphagia, Stroke, PNF Exercise, CTAR Exercise, Swallowing Rehabilitation
Eligibility Criteria
Inclusion Criteria: 18 years and older, Who have been diagnosed with stroke At least one month has passed since the diagnosis of stroke Voluntarily participated in the research, Cooperative, able to take instructions (Mini Mental Test score of 24 and above) and Individuals with a score of 2 or higher on the Penetration Aspiration Scale will be included. Exclusion Criteria: Lack of long-term sitting balance, unable to maintain an upright position with or without support, Have tumors or neoplastic disease in the head and neck region, Radiotherapy applied to the neck, swallowing disorders caused by radiotherapy applied to the head and neck region, With additional musculoskeletal disease that may cause swallowing disorders, With non-stroke neurological disease (Traumatic Brain Injury, Parkinson's, Dementia, ALS, MS, etc.), Individuals who have previously received dysphagia treatment will be excluded from the study.
Sites / Locations
- Selcuk University, Faculty of Medicine, Department of OtolaryngologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Routine Exercise Group
PNF Exercise
CTAR Exercise
Arm Description
Conventional swallowing therapy exercises will be given to the routine exercise group.
Head-neck PNF (Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to the participants with the combined isometric contraction technique.
CTAR (Chin Tuck Against Resistance) exercises will be applied to the participants.
Outcomes
Primary Outcome Measures
Penetration Aspiration Scale (PAS)
The penetration aspiration scale (PAS) is routinely used to assess penetration and aspiration severity during videofluoroscopic or FEES assessment. It has a scoring system from 0 to 8, depending on whether it is aspirated or penetrated after administration of liquid-consistent and solid foods with oral contrast agent or dye. High scores indicate the presence of aspiration and penetration.
Ultrasound Evaluation
Neck submental muscle cross-sectional thickness measurement (millimeter-mm), sternocleidomastoideus muscle thickness measurement (mm), hyoid bone elevation measurement (millimeter-mm) and tongue base cross-sectional area (square-centimeter-cm2) will be measured by USG before and after therapy. USG measurements will be made by an experienced radiologist. Three measurements will be taken from each muscle group and the results will be averaged to minimize variations in muscle thickness.
Secondary Outcome Measures
Cognitive Status
Mini Mental Test will be used to evaluate the cognitive status of individuals. It is a short, useful, standardized test that provides the opportunity to evaluate cognitive performance in a short time. A high score indicates a good cognitive status. The maximum possible score is 30. A score of 17 and below is considered severe dementia, a score of 18-23 is considered mild dementia, and a score of 24-30 is considered normal.
The Barthel Index
The Barthel index evaluates physical independence in activities of daily living in 10 items (transfer, ambulation/wheelchair use, stair climbing, feeding, dressing, self-regulation, bathing, toilet use, urinary continence, stool continence). Each item is scored separately as 0, 5, 10 or 15 points. A total score of 0-20 means fully dependent, 21-61 highly dependent, 62-90 moderately dependent, 91-99 mildly dependent and 100 fully independent.
Eating Assessment Tool (EAT-10)
It is an easy-to-apply scale consisting of ten items, which allows the rapid assessment of dysphagia symptoms in patients with swallowing disorders. It contains ten questions about oropharyngeal dysphagia, each question is scored between 0 and 3. The total score is obtained by summing the scores. High scores indicate severe dysphagia.
Functional Oral Intake Scale (FOIS)
Oral nutritional status of individuals will be evaluated by using The FOIS is a seven-item scale. It is used to show the level of an individual's feeding tube and oral intake. High scores indicate normal oral intake. The maximum score that can be obtained from the scale is 7.
Swallowing Quality Of Life Questionnaire (SWAL-QOL)
Quality of life due to swallowing problem will be evaluated with the Swallowing Quality of Life Questionnaire (SWAL-QOL). SWAL-QOL includes 10 concepts: general load, food choice, eating time, desire to eat, fear of eating, sleep, fatigue, communication, mental health, and social function. A high score indicates good quality of life. Since its creation, the SWAL-QOL questionnaire has been used as the gold standard in the assessment of quality of life in studies on swallowing disorders.
Full Information
NCT ID
NCT05678686
First Posted
December 23, 2022
Last Updated
December 23, 2022
Sponsor
Karamanoğlu Mehmetbey University
Collaborators
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05678686
Brief Title
Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients
Official Title
Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University
Collaborators
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to examine the effects of PNF (proprioceptive neuromuscular facilitation) and CTAR (Chin Tuck Against Resistance) exercises on swallowing rehabilitation in stroke patients. In addition another aim is to examine the effects of these exercises on the swallowing function, quality of life, functional independence and functional oral intake of individuals, and to investigate the superiority of the exercises to each other in line with these features.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia, Swallowing Disorder
Keywords
Dysphagia, Stroke, PNF Exercise, CTAR Exercise, Swallowing Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The physicians who will evaluate imaging methods will not know which arm they are in. In addition patricipants will not know which arm they are in.
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine Exercise Group
Arm Type
Active Comparator
Arm Description
Conventional swallowing therapy exercises will be given to the routine exercise group.
Arm Title
PNF Exercise
Arm Type
Experimental
Arm Description
Head-neck PNF (Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to the participants with the combined isometric contraction technique.
Arm Title
CTAR Exercise
Arm Type
Experimental
Arm Description
CTAR (Chin Tuck Against Resistance) exercises will be applied to the participants.
Intervention Type
Other
Intervention Name(s)
Active Comparator: Routine Exercise Group
Intervention Description
Exercises (tongue-palate exercises, tongue base exercises, Masako Maneuver, Mendelson Maneuver, Effortful Swallowing, Supraglottic exercises, thermal tactile stimulation) will be performed 2 days a week for 8 weeks, in total 16 sessions and these exercises applied by the physiotherapist.
Intervention Type
Other
Intervention Name(s)
Experimental: PNF Exercise
Intervention Description
In addition to the practices in the control group, head-neck PNF(Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to both movement patterns by the physiotherapist using the combined isotonic contraction technique ), 2 days a week for 8 weeks, in total 16 sessions.
Intervention Type
Other
Intervention Name(s)
Experimental: CTAR Exercise
Intervention Description
In addition to the practices in the control group, CTAR exercises will be applied in the presence of a physiotherapist, 2 days a week for 8 weeks, a total of 16 sessions. In the CTAR exercise, the patient is asked to flexion and extension the neck by pressing a standard size and inflatable rubber ball placed under his chin against his sternum. Patients will be asked to do the exercise protocol, which consists of isometric and isotonic components.
Primary Outcome Measure Information:
Title
Penetration Aspiration Scale (PAS)
Description
The penetration aspiration scale (PAS) is routinely used to assess penetration and aspiration severity during videofluoroscopic or FEES assessment. It has a scoring system from 0 to 8, depending on whether it is aspirated or penetrated after administration of liquid-consistent and solid foods with oral contrast agent or dye. High scores indicate the presence of aspiration and penetration.
Time Frame
Change from baseline at 8 weeks
Title
Ultrasound Evaluation
Description
Neck submental muscle cross-sectional thickness measurement (millimeter-mm), sternocleidomastoideus muscle thickness measurement (mm), hyoid bone elevation measurement (millimeter-mm) and tongue base cross-sectional area (square-centimeter-cm2) will be measured by USG before and after therapy. USG measurements will be made by an experienced radiologist. Three measurements will be taken from each muscle group and the results will be averaged to minimize variations in muscle thickness.
Time Frame
Change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Cognitive Status
Description
Mini Mental Test will be used to evaluate the cognitive status of individuals. It is a short, useful, standardized test that provides the opportunity to evaluate cognitive performance in a short time. A high score indicates a good cognitive status. The maximum possible score is 30. A score of 17 and below is considered severe dementia, a score of 18-23 is considered mild dementia, and a score of 24-30 is considered normal.
Time Frame
a day before the start of treatment
Title
The Barthel Index
Description
The Barthel index evaluates physical independence in activities of daily living in 10 items (transfer, ambulation/wheelchair use, stair climbing, feeding, dressing, self-regulation, bathing, toilet use, urinary continence, stool continence). Each item is scored separately as 0, 5, 10 or 15 points. A total score of 0-20 means fully dependent, 21-61 highly dependent, 62-90 moderately dependent, 91-99 mildly dependent and 100 fully independent.
Time Frame
Change from baseline at 8 weeks
Title
Eating Assessment Tool (EAT-10)
Description
It is an easy-to-apply scale consisting of ten items, which allows the rapid assessment of dysphagia symptoms in patients with swallowing disorders. It contains ten questions about oropharyngeal dysphagia, each question is scored between 0 and 3. The total score is obtained by summing the scores. High scores indicate severe dysphagia.
Time Frame
Change from baseline at 8 weeks
Title
Functional Oral Intake Scale (FOIS)
Description
Oral nutritional status of individuals will be evaluated by using The FOIS is a seven-item scale. It is used to show the level of an individual's feeding tube and oral intake. High scores indicate normal oral intake. The maximum score that can be obtained from the scale is 7.
Time Frame
Change from baseline at 8 weeks
Title
Swallowing Quality Of Life Questionnaire (SWAL-QOL)
Description
Quality of life due to swallowing problem will be evaluated with the Swallowing Quality of Life Questionnaire (SWAL-QOL). SWAL-QOL includes 10 concepts: general load, food choice, eating time, desire to eat, fear of eating, sleep, fatigue, communication, mental health, and social function. A high score indicates good quality of life. Since its creation, the SWAL-QOL questionnaire has been used as the gold standard in the assessment of quality of life in studies on swallowing disorders.
Time Frame
Change from baseline at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and older,
Who have been diagnosed with stroke
At least one month has passed since the diagnosis of stroke
Voluntarily participated in the research,
Cooperative, able to take instructions (Mini Mental Test score of 24 and above) and
Individuals with a score of 2 or higher on the Penetration Aspiration Scale will be included.
Exclusion Criteria:
Lack of long-term sitting balance, unable to maintain an upright position with or without support,
Have tumors or neoplastic disease in the head and neck region,
Radiotherapy applied to the neck, swallowing disorders caused by radiotherapy applied to the head and neck region,
With additional musculoskeletal disease that may cause swallowing disorders,
With non-stroke neurological disease (Traumatic Brain Injury, Parkinson's, Dementia, ALS, MS, etc.),
Individuals who have previously received dysphagia treatment will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Nur ÖZCAN, MSc
Phone
+905058554846
Email
esra.n.ozcan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nezehat Özgül ÜNLÜER, PhD
Phone
+905053009510
Email
nunluer80@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Nur ÖZCAN, MSc
Organizational Affiliation
Karamanoğlu Mehmetbey University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nezehat Özgül ÜNLÜER, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Study Chair
Facility Information:
Facility Name
Selcuk University, Faculty of Medicine, Department of Otolaryngology
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42131
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Nur ÖZCAN, MSc
Phone
+905058554846
Email
esra.n.ozcan@gmail.com
First Name & Middle Initial & Last Name & Degree
Nezehat Özgül ÜNLÜER, PhD
Phone
+905053009510
Email
nunluer80@yahoo.com
First Name & Middle Initial & Last Name & Degree
Esra Nur ÖZCAN, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients
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