Clinical trial NCT05290649: Respiratory Functions and Muscle Strength, Trunk Control, Functional Capacity and Independence in Hemiplegic Patients
Official title: The Relationship of Respiratory Functions and Respiratory Muscle Strength With Trunk Control, Functional Capacity and Functional Independence in Hemiplegic Patients After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
hemiplegia
respiratory function
respiratory muscle strength
trunk control
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Trunk Impairment Scale
timeFrame: at the enrollment
measure: Timed Up and Go Test
timeFrame: at the enrollment
measure: Barthel Index
timeFrame: at the enrollment
measure: FEV1 (liter)
timeFrame: at the enrollment
measure: FEV1 (%-percentage)
timeFrame: at the enrollment
measure: FVC (liter)
timeFrame: at the enrollment
measure: FVC (%-percentage)
timeFrame: at the enrollment
measure: FEV1/FVC (percentage)
timeFrame: at the enrollment
measure: Inspiratory muscle test
timeFrame: at the enrollment
measure: Expiratory muscle test
timeFrame: at the enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Seda Saka
Study officials:
affiliation: Haliç Üniversitesi: Halic Universitesi
name: Seda Saka, PT, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.