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

NCT05290649 | Completed

• 1 other identifier: ssaka2
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

stroke; hemiplegia; respiratory function; respiratory muscle strength; trunk control

Outcome Measures

Primary Outcomes (10)

• 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

  at the enrollment

• 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

  at the enrollment

• 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

  at the enrollment

• FEV1 (liter)

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

  at the enrollment

• FEV1 (%-percentage)

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

  at the enrollment

• FVC (liter)

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

  at the enrollment

• FVC (%-percentage)

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

  at the enrollment

• 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.

  at the enrollment

• 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).

  at the enrollment

• 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).

  at the enrollment

Interventions

clinical assessment DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Seda Saka

Istanbul, 34350, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 29848898 BACKGROUND

• 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.

  PMID: 31314840 BACKGROUND

• 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.

  PMID: 33489649 BACKGROUND

• 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.

  PMID: 32722338 BACKGROUND

• 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.

  PMID: 36408866 DERIVED

MeSH Terms

Conditions

Stroke; Hemiplegia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Seda Saka, PT, PhD

  Haliç Üniversitesi: Halic Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 22, 2022
• Study Start: November 10, 2019
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

TU (1)