Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454539
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-12
First Post:
2024-06-02
Brief Title:
The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training
Sponsor:
Istinye University
Organization:
Istinye University
Study Overview
Official Title:
The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training on Trunk Control and Respiratory Functions in Patients With Chronic Stroke
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None