Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients

January 7, 2024 updated by: Esra Nur ÖZCAN, Karamanoğlu Mehmetbey University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42131
        • Selcuk University, Faculty of Medicine, Department of Otolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Routine Exercise Group
Conventional swallowing therapy exercises will be given to the routine exercise group.
Other: Active Comparator: Routine Exercise Group
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.
Experimental: PNF Exercise
Head-neck PNF (Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to the participants with the combined isometric contraction technique.
Other: Experimental: PNF Exercise
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.
Experimental: CTAR Exercise
CTAR (Chin Tuck Against Resistance) exercises will be applied to the participants.
Other: Experimental: CTAR Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration Aspiration Scale (PAS)
Time Frame: Change from baseline at 8 weeks
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.
Change from baseline at 8 weeks
Ultrasound Evaluation
Time Frame: Change from baseline at 8 weeks
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.
Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Status
Time Frame: a day before the start of treatment
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.
a day before the start of treatment
The Barthel Index
Time Frame: Change from baseline at 8 weeks
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.
Change from baseline at 8 weeks
Eating Assessment Tool (EAT-10)
Time Frame: Change from baseline at 8 weeks
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.
Change from baseline at 8 weeks
Functional Oral Intake Scale (FOIS)
Time Frame: Change from baseline at 8 weeks
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.
Change from baseline at 8 weeks
Swallowing Quality Of Life Questionnaire (SWAL-QOL)
Time Frame: Change from baseline at 8 weeks
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.
Change from baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karamanoğlu Mehmetbey University

Collaborators

Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: Esra Nur ÖZCAN, MSc, Karamanoglu Mehmetbey University
  • Study Chair: Nezehat Özgül ÜNLÜER, PhD, Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU-EOZCAN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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