- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06342882
Dysphagia Severity and Functional Independence Level
Functional Independence Levels Associated With Dysphagia Severity in Patients With Neurological Diseases
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Incek
-
Ankara, Incek, Turkey, 06830
- Atılım Uiveristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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).
|
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 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).
|
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 was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
|
|
functional independence
Time Frame: 1 day
|
Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Selen serel arslan, Prof, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 19/833- A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysphagia
-
Istanbul University - CerrahpasaRecruitingDysphagia | Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationTurkey (Türkiye)
-
Morinaga Milk Industry Co., LTDHospital de MataróRecruitingDysphagia | Swallowing Disorder | Dysphagia, Oral Phase | Dysphagia, Esophageal | Dysphagia, OropharyngealSpain
-
Dongtan Sacred Heart HospitalCompleted
-
Christian SimonRecruitingDysphagia RehabilitationSwitzerland
-
University of BaghdadNot yet recruiting
-
Zhejiang Provincial People's HospitalNot yet recruitingDysphagia After Stroke
-
All India Institute of Medical Sciences, New DelhiRecruitingOropharyngeal Dysphagia | Dysphagia, Late Effect of Stroke | Transfer Dysphagia | Cricopharyngeus Muscle DysfunctionIndia
-
First Teaching Hospital of Tianjin University of...Recruiting
-
National Taiwan University HospitalRecruitingDysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationTaiwan
-
University of Southern CaliforniaRecruitingDysphagia | Pharyngeal Dysphagia | Oral Pharyngeal DysphagiaUnited States
Clinical Trials on dysphagia assessment
-
IRCCS San Camillo, Venezia, ItalyRecruiting
-
University of NottinghamNational Institute for Health Research, United KingdomCompletedDysphagia Following Cerebral Infarction | Dysphagia Following Nontraumatic Intracerebral HemorrhageUnited Kingdom
-
Istituti Clinici Scientifici Maugeri SpACompletedDysphagia | Neuro-Degenerative Disease | Swallowing DisorderItaly
-
Copenhagen University Hospital at HerlevCompleted
-
Riphah International UniversityActive, not recruiting
-
National Taiwan University HospitalNot yet recruitingSwallowing Contraction Strength
-
Vendsyssel HospitalCompleted
-
University of MiamiRecruiting
-
Hacettepe UniversityCompleted
-
University of CanterburyTan Tock Seng Hospital; University of Toronto; Fremantle Hospital and Health... and other collaboratorsCompletedStroke | Dysphagia | Cerebrovascular AccidentSingapore, Canada, Australia, New Zealand