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

NCT ID: NCT05678686

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Routine Exercise Group

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

Group Type: ACTIVE_COMPARATOR

Active Comparator: Routine Exercise Group

Intervention Type: 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.

PNF Exercise

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

Group Type: EXPERIMENTAL

Experimental: PNF Exercise

Intervention Type: 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.

CTAR Exercise

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

Group Type: EXPERIMENTAL

Experimental: CTAR Exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: collaborator

Karamanoğlu Mehmetbey University

OTHER

Sponsor Role: lead

Responsible Party

Esra Nur ÖZCAN

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra Nur ÖZCAN, MSc

Role: PRINCIPAL_INVESTIGATOR

Karamanoğlu Mehmetbey University

Nezehat Özgül ÜNLÜER, PhD

Role: STUDY_CHAIR

Ankara Yildirim Beyazıt University

Locations

Selcuk University, Faculty of Medicine, Department of Otolaryngology

Konya, Selcuklu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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 Jul 1. doi: 10.1111/joor.70000. Online ahead of print.

Reference Type: DERIVED

PMID: 40596755 (View on PubMed)

Other Identifiers

KMU-EOZCAN-001

Identifier Type: -

Identifier Source: org_study_id