- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290649
Respiratory Functions and Muscle Strength, Trunk Control, Functional Capacity and Independence in Hemiplegic Patients
The Relationship of Respiratory Functions and Respiratory Muscle Strength With Trunk Control, Functional Capacity and Functional Independence in Hemiplegic Patients After Stroke
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34350
- Seda Saka
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
It was performed in Aydın University Health Practice and Research Center Physical Therapy Unit.
When the literature is examined, it is reported that there are moderate correlations (r=0.578) between trunk control and respiratory muscle strength evaluation results. Based on this, it was calculated that the sample size should be 23 cases in order to have a medium level correlation (r=0.550) target, 80% power and 95% confidence level for our study
Description
Inclusion Criteria:
- diagnosis of ischemic stroke
- over age 40 years
- Brunnstrom stage 3-6.
Exclusion Criteria:
- having an additional clinical problem affecting lung functions,
- Mini-mental test score below 24,
- having another cardiovascular disease except stroke.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trunk Impairment Scale
Time Frame: at the enrollment
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Trunk control was assessed with Trunk Impairment Scale (TIS) that was developed to evaluate trunk control in patients with neurological problems consists of 17 parameters.
The parameters are scored between 0 and 3 in the scale in which static and dynamic sitting balance and trunk coordination are evaluated.
The best performance value was recorded after three repeated measurements in patients who could maintain their starting position
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at the enrollment
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Timed Up and Go Test
Time Frame: at the enrollment
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Functional capacity of subjects were evaluated with Time Up and Go Test (TUG).
TUG is widely used to evaluate functional capacity in stroke patients.
Test procedure was given to the patients before the test.
During the test, the subject was asked to stand up from the chair, walk 3 meters forward, turn 180 degrees where they were, walk back to the chair and sit on the chair again.
Test time was measured with a stopwatch and recorded.
Subjects performed the test three times with intervals and the best result was recorded
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at the enrollment
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Barthel Index
Time Frame: at the enrollment
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Functional independence was evaluated with Barthel Index (BI) which is one of the most frequently used scales for determining and tracking functional independence.
It basically evaluates mobility and self-care activities.
The test consists of 10 sections: nutrition, transfer, self-care, toilet use, bathroom, movement, use of wheelchairs (if using), climbing up and down stairs, dressing, bowel and bladder control (26, 27).
The total score is evaluated between 0-100; 0-20 points: fully dependent, 21-61 points: highly dependent, 62-90 points: moderately dependent, 91-99 points: slightly dependent, 100 points: fully independent
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at the enrollment
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FEV1 (liter)
Time Frame: at the enrollment
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This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
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at the enrollment
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FEV1 (%-percentage)
Time Frame: at the enrollment
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This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
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at the enrollment
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FVC (liter)
Time Frame: at the enrollment
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This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
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at the enrollment
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FVC (%-percentage)
Time Frame: at the enrollment
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This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
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at the enrollment
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FEV1/FVC (percentage)
Time Frame: at the enrollment
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The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
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at the enrollment
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Inspiratory muscle test
Time Frame: at the enrollment
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Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
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at the enrollment
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Expiratory muscle test
Time Frame: at the enrollment
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Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
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at the enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Seda Saka, PT, PhD, Haliç Üniversitesi: Halic Universitesi
Publications and helpful links
General Publications
- Lee K, Cho JE, Hwang DY, Lee W. Decreased Respiratory Muscle Function Is Associated with Impaired Trunk Balance among Chronic Stroke Patients: A Cross-sectional Study. Tohoku J Exp Med. 2018 Jun;245(2):79-88. doi: 10.1620/tjem.245.79.
- Santos RSD, Dall'alba SCF, Forgiarini SGI, Rossato D, Dias AS, Forgiarini Junior LA. Relationship between pulmonary function, functional independence, and trunk control in patients with stroke. Arq Neuropsiquiatr. 2019 Jul 15;77(6):387-392. doi: 10.1590/0004-282X20190048.
- Kubo H, Nozoe M, Yamamoto M, Kamo A, Noguchi M, Kanai M, Mase K, Shimada S. Recovery process of respiratory muscle strength in patients following stroke: A Pilot Study. Phys Ther Res. 2020 Jul 22;23(2):123-131. doi: 10.1298/ptr.E10006. eCollection 2020.
- Pozuelo-Carrascosa DP, Carmona-Torres JM, Laredo-Aguilera JA, Latorre-Roman PA, Parraga-Montilla JA, Cobo-Cuenca AI. Effectiveness of Respiratory Muscle Training for Pulmonary Function and Walking Ability in Patients with Stroke: A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2020 Jul 24;17(15):5356. doi: 10.3390/ijerph17155356.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ssaka2
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.
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