Chronic StrokeNCT06758791
Respiratory Muscle Functions With Balance and Gait in Stroke Patients
An observational study of Chronic Stroke and Respiratory Muscles, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Stroke, which can occur due to many different causes and is one of the most common neurological conditions, is one of the main causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke, Respiratory Muscles
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Dec 2024to 2 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic Stroke Patients
Who may be able to join
- Having had a stroke for the first time
- Being 18 years of age or older
- Having an ischemic type of stroke
- Having had a stroke for at least 6 months
- Having a Modified Rankin Score of ≥3
- Being able to communicate
- Agreeing to participate in the study
Who cannot join
- Hemispatial neglect
- Having a psychiatric disease
- Having any respiratory problems before the stroke
- Having any orthopedic, neurological, cardiopulmonary disease that would constitute a contraindication for the protocols to be applied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Beykent Üniversity
Istanbul, Büyükçekmece, 34500
About this study
Official title: Relationship of Respiratory Muscle Functions With Balance and Gait in Chronic Ischemic Stroke Patients
Stroke, which can occur due to many different causes and is one of the most common neurological conditions, is one of the main causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. In addition, respiratory problems such as changes in breathing patterns and decreased ventilation function may accompany these patients. Respiratory problems are an important risk factor in the development of long-term mortality for both cardiovascular diseases and stroke. With all these changes, a serious decrease in patients' activity performance is observed. While the focus is on motor function losses in stroke rehabilitation, problems in pulmonary functions do not receive the necessary attention. In stroke rehabilitation, evaluating and treating patients from every perspective will further increase the effectiveness of the treatments applied.
Read the detailed description
According to WHO, stroke, also known as cerebrovascular accident, is a neurological condition that results in rapidly developing loss of brain function as a result of a problem in the blood supply to the brain. Stroke, which ranks third among the causes of death, is one of the leading causes of disability. Brain damage following stroke affects the central control of respiration, leading to various respiratory disorders. Dysfunction of the main respiratory muscle, the diaphragm, and particularly of the respiratory muscles on the paretic side of the body, is the most common and serious problem, causing asymmetric chest wall movements, changes in respiratory patterns, decreased lung volumes, and pulmonary complications. These changes in respiration cause further decreases in aerobic capacity, walking function, and the ability to perform daily living activities, especially in stroke patients who require an intensive rehabilitation program, and may increase the risk of pulmonary complications. At the same time, this situation may increase the risk of mortality by 2-6 times in stroke patients in the acute phase, prolong the average hospital stay, and worsen neurological dysfunctions. Therefore, evaluation of pulmonary functions and respiratory muscles before rehabilitation is very important to protect patients from possible accompanying pulmonary complications and to increase the effectiveness of the treatment.
- Conditions
- Chronic Stroke, Respiratory Muscles
- Keywords
- Chronic Stroke, Ischemic, Respiratory Muscles, Pulmonary Funtion Test, Balance, Gait
- Medical subject headings
- Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Tests
These are tests used in combination with the clinic to evaluate and grade damage and abnormalities in respiratory system functions. Spirometric measurement reflects the time, volume and flow values measured during normal breathing, forced inspiration, forced expiration, deep and rapid breathing for a certain period of time. The test is evaluated by comparing the basal values obtained by creating gender, height, weight and age groups in healthy people in the community where the measurement is made. Lung functions physiologically consist of four volumes. Expiratory reserve volume (ERV), inspiratory reserve volume (IRV), residual volume (RV) and tidal volume (VT). The sum of the four volumes gives the total lung capacity (TLC).
Measured: 1 day (It will be performed one time.)
Secondary outcomes (2)
6-Minute Walk Test
The 6MWT is defined as a submaximal test that can be easily applied to healthy or sick individuals, and is evaluated as an indicator of exercise capacity and walking capacity, as well as many cardiovascular diseases. The 6MWT is referred to as the "Gold Standard" test of walking capacity.
Measured: 1 day (It will be performed one time.)
Berg Balance Scale
A scale consisting of 14 tests that measure the ability to maintain balance during different positions, postural changes and movement. The assessment is based on the person's ability to perform each test independently and/or for a certain time or distance. The rating is made between 0 and 4 points (0: cannot perform, 4: normal performance). The total score varies between 0 (dependent) and 56 (independent).
Measured: 1 day (It will be performed one time.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start28 Dec 2024
- Primary completion2 Mar 2025 (estimated)
- Study completion2 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Beykent
- Responsible party
- Principal investigator, Sümeyye Akçay, Saglik Bilimleri Universitesi
- Investigators
- İbrahim Halil Ural, M.D., Principal investigator, Beykent UniversityDudu Kübra Akyol, PT, Study chair, IAU Medical Park Florya HospitalSümeyye Akçay, PT, Study chair, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758791
- Sponsor's protocol ID
- BeykentUniversity
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Respiratory Muscle Functions With Balance and Gait in Chronic Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT06758791
- Acronym / sponsor ID
- BeykentUniversity
- Conditions
- Chronic Stroke, Respiratory Muscles
- Keywords
- Chronic Stroke, Ischemic, Respiratory Muscles, Pulmonary Funtion Test, Balance, Gait
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- University of Beykent
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 2 Mar 2025 (estimated)
- Study completion
- 2 Apr 2025 (estimated)
- First posted
- 6 Jan 2025 (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.
Stroke, which can occur due to many different causes and is one of the most common neurological conditions, is one of the main causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. In addition, respiratory problems such as changes in breathing patterns and decreased ventilation function may accompany these patients. Respiratory problems are an important risk factor in the development of long-term mortality for both cardiovascular diseases and stroke. With all these changes, a serious decrease in patients' activity performance is observed. While the focus is on motor function losses in stroke rehabilitation, problems in pulmonary functions do not receive the necessary attention. In stroke rehabilitation, evaluating and treating patients from every perspective will further increase the effectiveness of the treatments applied.
Detailed description
According to WHO, stroke, also known as cerebrovascular accident, is a neurological condition that results in rapidly developing loss of brain function as a result of a problem in the blood supply to the brain. Stroke, which ranks third among the causes of death, is one of the leading causes of disability. Brain damage following stroke affects the central control of respiration, leading to various respiratory disorders. Dysfunction of the main respiratory muscle, the diaphragm, and particularly of the respiratory muscles on the paretic side of the body, is the most common and serious problem, causing asymmetric chest wall movements, changes in respiratory patterns, decreased lung volumes, and pulmonary complications. These changes in respiration cause further decreases in aerobic capacity, walking function, and the ability to perform daily living activities, especially in stroke patients who require an intensive rehabilitation program, and may increase the risk of pulmonary complications. At the same time, this situation may increase the risk of mortality by 2-6 times in stroke patients in the acute phase, prolong the average hospital stay, and worsen neurological dysfunctions. Therefore, evaluation of pulmonary functions and respiratory muscles before rehabilitation is very important to protect patients from possible accompanying pulmonary complications and to increase the effectiveness of the treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic Stroke Patients
Key inclusion criteria (7 listed)
- Having had a stroke for the first time
- Being 18 years of age or older
- Having an ischemic type of stroke
- Having had a stroke for at least 6 months
- Having a Modified Rankin Score of ≥3
Key exclusion criteria (4 listed)
- Hemispatial neglect
- Having a psychiatric disease
- Having any respiratory problems before the stroke
- Having any orthopedic, neurological, cardiopulmonary disease that would constitute a contraindication for the protocols to be applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Function Tests
Time frame: 1 day (It will be performed one time.)
These are tests used in combination with the clinic to evaluate and grade damage and abnormalities in respiratory system functions. Spirometric measurement reflects the time, volume and flow values measured during normal breathing, forced inspiration, forced expiration, deep and rapid breathing for a certain period of time. The test is evaluated by comparing the basal values obtained by creating gender, height, weight and age groups in healthy people in the community where the measurement is made. Lung functions physiologically consist of four volumes. Expiratory reserve volume (ERV), inspiratory reserve volume (IRV), residual volume (RV) and tidal volume (VT). The sum of the four volumes gives the total lung capacity (TLC).
2 secondary outcomes
6-Minute Walk Test
Time frame: 1 day (It will be performed one time.)
Berg Balance Scale
Time frame: 1 day (It will be performed one time.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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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.
İbrahim Halil Ural, M.D. principal investigator
Beykent University
Dudu Kübra Akyol, PT study chair
IAU Medical Park Florya Hospital
Sümeyye Akçay, PT study chair
Saglik Bilimleri 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 Chronic Stroke and Respiratory Muscles, run by Saglik Bilimleri Universitesi 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 7 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Respiratory Function Tests (time frame: 1 day (It will be performed one time.)). 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 14 Jan 2025.