DysphagiaNCT06342882
Dysphagia Severity and Functional Independence Level
An observational study of Dysphagia and Neurologic Disorder, run by Atılım University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysphagia, Neurologic Disorder
- What is being tested?
- dysphagia assessment and functional independence level
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neurological disorders
Who may be able to join
- aged between 18-65 years
- independent to walk 3 meters
- underwent a Modified Barium Swallowing Study (MBSS).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dysphagia, Neurologic Disorder
- Being tested
- dysphagia assessment, functional independence level
- Keywords
- dysphagia, functional independance
- Medical subject headings
- Deglutition Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dysphagia assessmentDiagnostic 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 levelDiagnostic test
Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: dysphagia assessment; Diagnostic Test: functional independence level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
functional independence
Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jan 2020
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- selen serel arslan, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342882
- Sponsor's protocol ID
- GO 19/833- A
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Independence Levels Associated With Dysphagia Severity in Patients With Neurological Diseases
- ClinicalTrials.gov ID
- NCT06342882
- Acronym / sponsor ID
- GO 19/833- A
- Conditions
- Dysphagia, Neurologic Disorder
- Keywords
- dysphagia, functional independance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with dysphagia (study) | – | Diagnostic Test: dysphagia assessment, Diagnostic Test: functional independence levelIn 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) | – | Diagnostic Test: dysphagia assessment, Diagnostic Test: functional independence levelIn 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neurological disorders
Key inclusion criteria (3 listed)
- aged between 18-65 years
- independent to walk 3 meters
- underwent a Modified Barium Swallowing Study (MBSS).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dysphagia assessmentTwenty-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. | Diagnostic test | patients with dysphagia (study), patients without dysphagia (control) |
| functional independence levelFunctional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains. | Diagnostic test | patients with dysphagia (study), patients without dysphagia (control) |
Primary outcome
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.
functional independence
Time frame: 1 day
Functional independence was evaluated by the Functional Independence Measurement (FIM) motor and cognitive domains.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
selen serel arslan, Prof study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Neurologic Disorder, run by Atılım University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dysphagia severity (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.