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Clinical Trials/NCT05678686
NCT05678686
Completed
Not Applicable

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

Karamanoğlu Mehmetbey University1 site in 1 country42 target enrollmentOctober 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Karamanoğlu Mehmetbey University
Enrollment
42
Locations
1
Primary Endpoint
Ultrasound Evaluation
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2022
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karamanoğlu Mehmetbey University
Responsible Party
Principal Investigator
Principal Investigator

Esra Nur ÖZCAN

Lecturer

Karamanoğlu Mehmetbey University

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

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

Study Sites (1)

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