Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. But, there is no study in literature that aims to increase respiratory muscle strength in these children. Hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.

Detailed Description
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A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).

Official Title
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Effects of Inspiratory Muscle Training on Respiratory Functions, Trunk Control, Activities of Daily Living, Functional Exercise Capacity and Quality of Life in Children With Cerebral Palsy

Conditions
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Cerebral Palsy, Respiration; Decreased

Intervention / Treatment
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* Device: Threshold (IMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 7-14 years Diagnosed to spastic cerebral palsy Gross Motor Function Classification System levels I or II. Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments Child are able to demonstrate sufficient co-operation and cognitive understanding participating Exclusion Criteria: Active medical condition impairment (pneumonia etc.) Do not accommodate the study Do not want to attempt the study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load. | Device: Threshold (IMT)<br>* Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.<br>|
| Sham Comparator: Control Group<br>The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT. | Device: Threshold (IMT)<br>* Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go Test | this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living using with Pediatric Evaluation of Disability Inventory | PEDI scale | 6 weeks | 
| Pulmonary Function Test | spirometry | 6 weeks | 
| Respiratory muscle strength | Mouth pressure device | 6 weeks | 
| Functional exercise capacity | six minute walk test | 6 weeks | 
| Change in trunk control over time assessed with Trunk Control Measurement Scale | Assessing change in trunk control | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, inspiratory muscle training