Dysphagia Severity and Functional Independence Level

Dysphagia Clinical Trial

Official title:

Functional Independence Levels Associated With Dysphagia Severity in Patients With Neurological Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06342882
• Other study ID #: GO 19/833- A
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Atilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Nervous System Diseases
• Neurologic Disorder

Intervention

Diagnostic Test:
• 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.
• functional independence level
Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.

Locations

Country	Name	City	State
Turkey	Atilim Uiveristy	Ankara	Incek

Sponsors (1)

Lead Sponsor	Collaborator
Atilim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	functional independence	Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.	1 day