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StrokeNCT05290649

Respiratory Functions and Muscle Strength, Trunk Control, Functional Capacity and Independence in Hemiplegic Patients

An observational study of Stroke, run by Halic University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to invastigate the relationship between respiratory functions and respiratory muscle strength with trunk control, functional capacity and functional independence in hemiplegic patients after stroke. In our study, 25 hemiplegic patients were included on a voluntary basis. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Stroke
What is being tested?
clinical assessment
How many people
25 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Nov 2019to 6 Apr 2020
How long will I take part?
1 Day
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 40 to 75 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • diagnosis of ischemic stroke
  • over age 40 years
  • Brunnstrom stage 3-6.

Who cannot join

  • having an additional clinical problem affecting lung functions,
  • Mini-mental test score below 24,
  • having another cardiovascular disease except stroke.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Seda Saka

    Istanbul, 34350

Other trials in Turkey (Türkiye)

About this study

Official title: The Relationship of Respiratory Functions and Respiratory Muscle Strength With Trunk Control, Functional Capacity and Functional Independence in Hemiplegic Patients After Stroke

The aim of this study was to invastigate the relationship between respiratory functions and respiratory muscle strength with trunk control, functional capacity and functional independence in hemiplegic patients after stroke. In our study, 25 hemiplegic patients were included on a voluntary basis. Pulmonary function test (PFT) for respiratory functions, mouth pressure measurement (MIP: maximal ınspiratory pressure, MEP: maximal expiratory pressure) for respiratory muscle strenght. Trunk Impairment Scale (TIS) for trunk control, and Time Up and Go Test (TUG) for functional capacity and Barthel Index (BI) for functional independence assessment were used.

Read the detailed description

Stroke is a clinical picture where motor loss, emotional and balance disororder, speech and cognitive functions are seen as a obstruction or rupture of cerebral vessels. %10 of patients with stroke recover spontaneously within the first month: the other %10 do not respond treatment. %80 of patients need rehabilitation. The purpose of stroke rehabilitation is to provide individuals with the functional capacity and functional indepence they need in the shortest time. The aim of this study was to invastigate the relationship between respiratory functions and respiratory muscle strength with trunk control, functional capacity and functional independence in hemiplegic patients after stroke. In our study, 25 hemiplegic patients were included on a voluntary basis. Pulmonary function test (PFT) for respiratory functions, mouth pressure measurement (MIP: maximal ınspiratory pressure, MEP: maximal expiratory pressure) for respiratory muscle strenght. Trunk Impairment Scale (TIS) for trunk control, and Time Up and Go Test (TUG) for functional capacity and Barthel Index (BI) for functional independence assessment were used.

Conditions
Stroke
Being tested
clinical assessment
Keywords
stroke, hemiplegia, respiratory function, respiratory muscle strength, trunk control
Medical subject headings
Stroke, Hemiplegia, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical assessmentDiagnostic test

    mini mental test, pulmonary function test, respiratory muscle strength test, trunk impairment scale, timed up and go test, barthel index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trunk Impairment Scale

    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

    Measured: at the enrollment

  2. Timed Up and Go Test

    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

    Measured: at the enrollment

  3. Barthel Index

    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

    Measured: at the enrollment

  4. FEV1 (liter)

    This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.

    Measured: at the enrollment

  5. FEV1 (%-percentage)

    This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.

    Measured: at the enrollment

  6. FVC (liter)

    This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.

    Measured: at the enrollment

  7. FVC (%-percentage)

    This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.

    Measured: at the enrollment

  8. FEV1/FVC (percentage)

    The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.

    Measured: at the enrollment

  9. Inspiratory muscle test

    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).

    Measured: at the enrollment

  10. Expiratory muscle test

    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).

    Measured: at the enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start10 Nov 2019
  3. Primary completion6 Apr 2020
  4. Study completion6 Apr 2020

Resources

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
Case only
Time perspective
Prospective
Enrolment
25 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05290649
Sponsor's protocol ID
ssaka2
Status last verified
Aug 2025
First submitted
18 Feb 2022
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 29848898

  • 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.

    PubMed 31314840

  • 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.

    PubMed 33489649

  • 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.

    PubMed 32722338

  • Boz K, Saka S, Cetinkaya I. The relationship of respiratory functions and respiratory muscle strength with trunk control, functional capacity, and functional independence in post-stroke hemiplegic patients. Physiother Res Int. 2023 Apr;28(2):e1985. doi: 10.1002/pri.1985. Epub 2022 Nov 21.

    PubMed 36408866

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Halic 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 3 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 15 Aug 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?

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?

Trunk Impairment Scale (time frame: at the enrollment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05290649, which also lists 5 linked publications.

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 15 Aug 2025.

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