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

NCT05678686 | Completed

• 1 other identifier: KMU-EOZCAN-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Dysphagia; Swallowing Disorder

Keywords

Dysphagia; Stroke; PNF Exercise; CTAR Exercise; Swallowing Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline at 8 weeks

• 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.

  Change from baseline at 8 weeks

Secondary Outcomes (5)

• Cognitive Status

  a day before the start of treatment

• The Barthel Index

  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

• Swallowing Quality Of Life Questionnaire (SWAL-QOL)

  Change from baseline at 8 weeks

Study Arms (3)

Routine Exercise Group

ACTIVE COMPARATOR

Conventional swallowing therapy exercises will be given to the routine exercise group.

Other: Active Comparator: Routine Exercise Group

PNF Exercise

EXPERIMENTAL

Head-neck PNF (Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to the participants with the combined isometric contraction technique.

Other: Experimental: PNF Exercise

CTAR Exercise

EXPERIMENTAL

CTAR (Chin Tuck Against Resistance) exercises will be applied to the participants.

Other: Experimental: CTAR Exercise

Interventions

Active Comparator: Routine Exercise Group OTHER

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.

Routine Exercise Group

Experimental: PNF Exercise OTHER

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.

PNF Exercise

Experimental: CTAR Exercise OTHER

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.

CTAR Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• Ankara Yildirim Beyazıt University: collaborator

Study Sites (1)

Selcuk University, Faculty of Medicine, Department of Otolaryngology

Konya, Selcuklu, 42131, Turkey (Türkiye)

Location

Related Publications (1)

• Ozcan EN, Unluer NO, Ozturk M, Erdur O. Does Proprioceptive Neuromuscular Facilitation Approach Have an Effect on Swallowing Function, Muscle Morphology and Quality of Life in Dysphagic Stroke Patients? A Randomised Controlled Trial. J Oral Rehabil. 2025 Nov;52(11):2044-2058. doi: 10.1111/joor.70000. Epub 2025 Jul 1.

  PMID: 40596755 DERIVED

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Esra Nur ÖZCAN, MSc

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

• Nezehat Özgül ÜNLÜER, PhD

  Ankara Yildirim Beyazıt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: October 3, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)