Skip to main content
OpenTrials
Completed

NCT Number: NCT06342882

Dysphagia Severity and Functional Independence Level

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Atılım Uiveristy

Ankara, Incek, 06830, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

functional independence level

Diagnostic Test

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

Primary outcomes

  1. dysphagia severity

    Time frame: 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.

  2. functional independence

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Atılım University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2024
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.