Dysphagia Severity and Functional Independence Level

Completed

• Conditions: Neurologic Disorder; Dysphagia
• Interventions: Diagnostic Test: dysphagia assessment; Diagnostic Test: functional independence level

• Registration Number: NCT06342882
• Lead Sponsor: Atılım University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01
• Study First Submitted: 2024-02-19
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with dysphagia (study)	functional independence level	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).
patients without dysphagia (control)	functional independence level	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).
patients with dysphagia (study)	dysphagia assessment	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).
patients without dysphagia (control)	dysphagia assessment	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).

Primary Outcome Measures

Name	Time	Method
dysphagia severity	1 day	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.
functional independence	1 day	Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.

Trial Locations

Locations (1)

Atılım Uiveristy; 🇹🇷 Ankara, Incek, Turkey