Clinical trial NCT06758791: Respiratory Muscle Functions With Balance and Gait in Stroke Patients
Official title: Relationship of Respiratory Muscle Functions With Balance and Gait in Chronic Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Stroke
Respiratory Muscles
Keywords: Chronic Stroke
Ischemic
Respiratory Muscles
Pulmonary Funtion Test
Balance
Gait
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: University of Beykent
First posted: 2025-01-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ischemic Stroke Patients

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Having had a stroke for the first time
2. Being 18 years of age or older
3. Having an ischemic type of stroke
4. Having had a stroke for at least 6 months
5. Having a Modified Rankin Score of ≥3
6. Being able to communicate
7. Agreeing to participate in the study

Exclusion Criteria:

1. Hemispatial neglect
2. Having a psychiatric disease
3. Having any respiratory problems before the stroke
4. Having any orthopedic, neurological, cardiopulmonary disease that would constitute a contraindication for the protocols to be applied

Primary outcomes:
measure: Respiratory Function Tests
timeFrame: 1 day (It will be performed one time.)
Secondary outcomes:
measure: 6-Minute Walk Test
timeFrame: 1 day (It will be performed one time.)
measure: Berg Balance Scale
timeFrame: 1 day (It will be performed one time.)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beykent Üniversity
state: Büyükçekmece
Study officials:
affiliation: Beykent University
name: İbrahim Halil Ural, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: IAU Medical Park Florya Hospital
name: Dudu Kübra Akyol, PT
role: STUDY_CHAIR
affiliation: Saglik Bilimleri University
name: Sümeyye Akçay, PT
role: STUDY_CHAIR
References: