Dysphagia Severity and Functional Independence Level

NCT06342882 | Completed

• 1 other identifier: GO 19/833- A
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

dysphagia; functional independance

Outcome Measures

Primary Outcomes (2)

• dysphagia severity

  Swallowing Study and Swallowing Ability and Function Evaluation (SAFE) assessments. The SAFE physical examination, oral phase and pharyngeal phase domains was used to determine the dysphagia severity.

  1 day

• functional independence

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

  1 day

Study Arms (2)

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).

Diagnostic Test: dysphagia assessment; Diagnostic Test: functional independence level

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).

Diagnostic Test: dysphagia assessment; Diagnostic Test: functional independence level

Interventions

dysphagia assessment 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.

patients with dysphagia (study); patients without dysphagia (control)

functional independence level DIAGNOSTIC_TEST

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

patients with dysphagia (study); patients without dysphagia (control)

Eligibility Criteria

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

Study Population

Patients with neurological disorders

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atılım University: lead

Study Sites (1)

Atılım Uiveristy

Ankara, Incek, 06830, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders; Nervous System Diseases

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• selen serel arslan, Prof

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: April 2, 2024
• Study Start: January 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

TU (1)