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Completed

NCT Number: NCT05290649

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seda Saka

Istanbul, 34350, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical assessment

Diagnostic Test

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

Primary outcomes

  1. Trunk Impairment Scale

    Time frame: at the enrollment

    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

  2. Timed Up and Go Test

    Time frame: at the enrollment

    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

  3. Barthel Index

    Time frame: at the enrollment

    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

  4. FEV1 (liter)

    Time frame: at the enrollment

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

  5. FEV1 (%-percentage)

    Time frame: at the enrollment

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

  6. FVC (liter)

    Time frame: at the enrollment

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

  7. FVC (%-percentage)

    Time frame: at the enrollment

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

  8. FEV1/FVC (percentage)

    Time frame: at the enrollment

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

  9. Inspiratory muscle test

    Time frame: at the enrollment

    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).

  10. Expiratory muscle test

    Time frame: at the enrollment

    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).

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2022
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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