The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training on Trunk Control and Respiratory Functions in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Measurement of respiratory muscle strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Measurement of respiratory muscle strength
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Yunus Emre Tutuneken
Principal Investigator
Istinye University