Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06454539 |
Other study ID # |
1 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 15, 2024 |
Est. completion date |
March 15, 2025 |
Study information
Verified date |
June 2024 |
Source |
Istinye University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study aims to compare the effectiveness of functional inspiratory muscle training (IMT)
versus inspiratory muscle training on trunk control, respiratory parameters, activity, and
participation in chronic stroke patients. The study is a prospective, randomized, and
parallel study. Forty-four stroke patients who meet the inclusion and exclusion criteria will
be included in the study. The patients to be included in the study will be divided into equal
numbers into two groups, F-IMT Group, and IMT Group, by block randomization method.
Participants' trunk control will be measured with the Trunk Disability Scale and Trunk
Control Test, respiratory parameters will be measured with respiratory muscle strength
measurement test and respiratory function test, balance and gait will be measured with the
Berg Balance Scale, and core muscle will be measured with pressurized biofeedback unit,
exercise capacity will be measured by 6 minutes of walking. In the test, the level of
independence in daily living activities will be evaluated with the Barthel Activities of
Daily Living Index and treatment satisfaction with the Global Change Scale. Participants in
the Functional IMT Group will perform supervised functional IMT 3 days a week, and IMT as a
home program on 2 different days. In functional IMT, participants will perform breathing
exercises with the device while simultaneously performing exercises based on the
neurodevelopmental treatment approach given below. Exercises will be applied progressively,
taking into account the functional status of stroke patients. Participants in the IMT Group
will perform supervised exercises and IMT based on a neurodevelopmental treatment approach 3
days a week, and IMT as a home program on 2 different days.
Description:
This study aims to compare the effectiveness of functional inspiratory muscle training (IMT)
versus inspiratory muscle training on trunk control, respiratory parameters, activity, and
participation in chronic stroke patients.
For this purpose, our hypotheses were determined as follows:
H0: There is no difference between the effects of inspiratory muscle training and functional
inspiratory muscle training applied in addition to the neurodevelopmental treatment approach
in chronic stroke patients on trunk control, respiratory muscle strength, respiratory
parameters, walking, balance, core muscles, functional capacity, daily living activities, and
exercise adaptation.
H1: There is a difference between the effects of inspiratory muscle training and functional
inspiratory muscle training applied in addition to the neurodevelopmental treatment approach
in chronic stroke patients on trunk control, respiratory muscle strength, respiratory
parameters, walking, balance, core muscles, functional capacity, daily living activities and
exercise adaptation. has.
The study is a prospective, randomized, and parallel study. Forty-four stroke patients who
meet the inclusion and exclusion criteria will be included in the study. The patients to be
included in the study will be divided into equal numbers into two groups, F-IMT Group, and
IMT Group, by block randomization method. Participants' trunk control will be measured with
the Trunk Disability Scale and Trunk Control Test, respiratory parameters will be measured
with respiratory muscle strength measurement test and respiratory function test, balance and
gait will be measured with the Berg Balance Scale, and core muscle will be measured with
pressurized biofeedback unit, exercise capacity will be measured by 6 minutes of walking. In
the test, the level of independence in daily living activities will be evaluated with the
Barthel Activities of Daily Living Index and treatment satisfaction with the Global Change
Scale. Participants in the Functional IMT Group will perform supervised functional IMT 3 days
a week, and IMT as a home program on 2 different days. In functional IMT, participants will
perform breathing exercises with the device while simultaneously performing exercises based
on the neurodevelopmental treatment approach given below. Exercises will be applied
progressively, taking into account the functional status of stroke patients. Participants in
the IMT Group will perform supervised exercises and IMT based on neurodevelopmental treatment
approach 3 days a week, and IMT as a home program on 2 different days. Rehabilitation
programs for stroke patients focus more on physical recovery and training on respiratory
functions is kept in the background. It is expected that the inclusion of Functional IMT, an
integrated exercise program that includes inspiratory muscle functions, in the rehabilitation
programs of stroke patients will contribute to closing this gap. The unique value of our
study is that it is conducted in stroke patients and compares the effects of Functional IMT
and IMT.
In light of the data obtained from the study, it is expected that Functional IMT can be used
by physiotherapists in the clinic and will contribute to other possible research.