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Clinical Trials/NCT06454539
NCT06454539CompletedNot Applicable

The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training on Trunk Control and Respiratory Functions in Patients With Chronic Stroke

Istinye University1 site in 1 country44 target enrollmentStarted: June 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Measurement of respiratory muscle strength

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Must have been diagnosed with unilateral cerebral lesions Must be able to have been diagnosed with a stroke at least 6 months ago Must be able to the mini-mental test result is more than 24 points Having a score of 3 or above on the functional ambulation scale Must be able to follow instructions and participate in work procedures Must be able to give informed consent and volunteering

Exclusion Criteria

  • •Neurological disease and transient ischemic attack Multiple strokes Signs of increased intracranial pressure Uncontrolled hypertension (blood pressure higher than 150/90 on three or more occasions in the last 24 hours) Gastrocnemius muscle severely spasticity Myocardial infarction, angina, or acute heart failure in the last 3 months Uncontrollable chronic disease

Arms & Interventions

F-IMT Group

Experimental

Participants in this group will apply functional IMT as a supervised program 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.

Intervention: Functional Inspiratory Muscle Training (Other)

IMT Group

Active Comparator

Participants in this group will perform supervised neurodevelopmental treatment approach-based exercises and IMT 3 days a week, and IMT as a home program on 2 different days.

Intervention: Inspiratory Muscle Training (Other)

Outcomes

Primary Outcomes

Measurement of respiratory muscle strength

Time Frame: Ten week

In the evaluation of respiratory muscle strength, maximum inspiratory intraoral pressure (MIP) and maximum expiratory intraoral pressure (MEP) will be measured using a portable, electronic oral pressure measuring device, and their values will be recorded in cmH2O. Assessment of respiratory muscle strength will be measured with a portable, electronic oral pressure measurement device (Micro Medical Micro RPM, Rochester, England).

Measurement of respiratory muscle endurance

Time Frame: Ten week

Patients will undergo muscle endurance testing at increasing threshold load. The test will be performed twice on the same day, 15 minutes apart. Test times will be calculated and recorded in seconds. The result value will be obtained by multiplying the test time and the pressure value corresponding to the time.

Trunk Control Test

Time Frame: Ten week

It is a scale obtained by modifying the scoring of the first special clinical scale developed to evaluate trunk control. The scale consists of four items, each of which is evaluated over three points (0-15-25), and the total score is min;0 - max:100.

Trunk Impairment Scale

Time Frame: Ten week

It is a test developed to evaluate the trunk control of stroke patients. It includes 3 subheadings that evaluate static sitting balance, dynamic sitting balance, and coordination. It includes 3 questions on static sitting balance, 10 questions on dynamic sitting balance, and 4 questions on coordination. It is scored between 0 and 23. 0 is the lowest value and 23 is the highest value and indicates good trunk control.

Secondary Outcomes

  • Six Minute Walk Test (6MWT)(Ten week)
  • Pulmonary function test(Ten week)
  • PRONE test(Ten week)
  • Berg Balance Scale (BDS)(Ten week)
  • Barthel Index for Activities of Daily Living (ADL)(Ten week)
  • Evaluation of treatment satisfaction(One week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yunus Emre Tutuneken

Principal Investigator

Istinye University

Study Sites (1)

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