Dysphagia Severity and Functional Independence Level

NCT ID: NCT06342882

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-02-01

Brief Summary

Functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. The functional independence depends on physical, social, cognitive and psychological abilities of the person. Therefore, full functional independence requires the harmony of all these parameters.

Dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. Muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. Pain and fatigue are also frequently observe. These patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. Life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. Both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. Neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding.

Dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. In a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. Decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. Other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (ADL). These studies also suggest that dysphagia may be associated with functional independence in geriatric group. Therefore, functional independence may also reduce in patients with neurogenic dysphagia. However, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. Therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases.

Conditions

Dysphagia; Neurologic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

patients with dysphagia (study)

In this study, patients who received PAS score 1 were included in the group without dysphagia (control group); and patients who were scored between 2 to 8 were included in the group with dysphagia (study group).

dysphagia assessment

Intervention Type: DIAGNOSTIC_TEST

Twenty-one patients underwent the Modified Barium Swallowing Study and Swallowing Ability and Function Evaluation (SAFE) assessments. The Penetration Aspiration Scale (PAS) and SAFE physical examination, oral phase and pharyngeal phase domains was used to determine the dysphagia severity.

functional independence level

Intervention Type: DIAGNOSTIC_TEST

Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.

patients without dysphagia (control)

In this study, patients who received PAS score 1 were included in the group without dysphagia (control group); and patients who were scored between 2 to 8 were included in the group with dysphagia (study group).

dysphagia assessment

Intervention Type: DIAGNOSTIC_TEST

Twenty-one patients underwent the Modified Barium Swallowing Study and Swallowing Ability and Function Evaluation (SAFE) assessments. The Penetration Aspiration Scale (PAS) and SAFE physical examination, oral phase and pharyngeal phase domains was used to determine the dysphagia severity.

functional independence level

Intervention Type: DIAGNOSTIC_TEST

Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.

Interventions

dysphagia assessment

Twenty-one patients underwent the Modified Barium Swallowing Study and Swallowing Ability and Function Evaluation (SAFE) assessments. The Penetration Aspiration Scale (PAS) and SAFE physical examination, oral phase and pharyngeal phase domains was used to determine the dysphagia severity.

Intervention Type: DIAGNOSTIC_TEST

functional independence level

Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• aged between 18-65 years
• independent to walk 3 meters
• underwent a Modified Barium Swallowing Study (MBSS).

Exclusion Criteria

• having any cervical pathology that may affect swallowing physiology,
• history of rheumatological diseases
• having any orthopedic surgery in the previous 6 months
• using a wheelchair.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atılım University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

selen serel arslan, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Atılım Uiveristy

Ankara, Incek, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GO 19/833- A

Identifier Type: -

Identifier Source: org_study_id