BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System

Status Completed

Clinical Trial Summary

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:

1. Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.

2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.

3. 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

Clinical Trial Description

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:

1. Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced Expiratory Volume in one,Tidal Volume.

2. Biofeedback

3. Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.

4. Gross Motor Function Classification System

5. Gross Motor Function Measure

6. Functional Mobility Scale

7. Children Assessment of Participation and Enjoyment

8. Autonomic function questionnaire ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01872507
Study type	Interventional
Source	Hadassah Medical Organization
Contact
Status	Completed
Phase	N/A
Start date	July 2013
Completion date	January 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms