- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758791
Respiratory Muscle Functions With Balance and Gait in Stroke Patients
January 11, 2025 updated by: Sümeyye Akçay, Saglik Bilimleri Universitesi
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.
Study Overview
Status
Enrolling by invitation
Conditions
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 Type
Observational
Enrollment (Estimated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Büyükçekmece
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Istanbul, Büyükçekmece, Turkey, 34500
- Beykent University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Ischemic Stroke Patients
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
1 day (It will be performed one time.)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Minute Walk Test
Time Frame: 1 day (It will be performed one time.)
|
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.
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1 day (It will be performed one time.)
|
|
Berg Balance Scale
Time Frame: 1 day (It will be performed one time.)
|
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).
|
1 day (It will be performed one time.)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Dudu Kübra Akyol, PT, IAU Medical Park Florya Hospital
- Principal Investigator: İbrahim Halil Ural, M.D., Beykent University
- Study Chair: Sümeyye Akçay, PT, Saglik Bilimleri University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2024
Primary Completion (Estimated)
March 2, 2025
Study Completion (Estimated)
April 2, 2025
Study Registration Dates
First Submitted
December 28, 2024
First Submitted That Met QC Criteria
January 3, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 11, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BeykentUniversity
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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