BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System in Children With Cerebral-Palsy.

Study Overview
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Brief Summary
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The effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy. Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. There are a few researches that investigated the autonomic function in cerebral palsy children. Those researches found hyperactivity of the sympathetic autonomic system, including high resting heart rate compare to their typically developed pears. The recommended treatment for cerebral palsy is activity, muscle strengthening and mobility. The impairment in the autonomic system influences the everyday function and has correlation with secondary morbidity. As far as we know there are no researches who investigated the following issues. In this study we would like to: Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing. Test the influence of breathing training on Heart rate variability parameters at rest, in aerobic test right after the breathing training program and one month after, in children with cerebral palsy

Detailed Description
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Participants: 60 children with cerebral palsy age 6-11 who can walk and understand simple instructions. Main outcome measures: Heart rate variability using Polar watch and transmitter RS810CX. Secondary outcome measures: Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced Expiratory Volume in one,Tidal Volume. Biofeedback Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter. Gross Motor Function Classification System Gross Motor Function Measure Functional Mobility Scale Children Assessment of Participation and Enjoyment Autonomic function questionnaire

Official Title
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The Effect of Breathing Biofeedback Training to Influence the Function of the Cardiac Autonomic Nervous System at Rest and in Activity in Children With Cerebral Palsy.

Conditions
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Cerebral Palsy, Autonomic Nerveus System

Intervention / Treatment
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* Other: Biofeedback training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with cerebral palsy age 6-11 years able to walk both gender Exclusion Criteria: heart or lung known disease can not follow simple commends

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: biofeedback training<br>usual treatment+12 treatment of biofeedback training | Other: Biofeedback training<br>* usual treatment +12 biofeedback training<br>|
| No Intervention: control<br>usual treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Heart rate variability meaures at one and two months |  | Change from Baseline at one and two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume, |  | Change from Baseline at one and two month | 
| Change from Baseline Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter. |  | Change from baseline at one and two month later | 
| Change from baseline breathing rate, by biofeedback |  | Change from baseline at one and two month later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, autonomic nerveus system, heart rate variability