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Completed

NCT Number: NCT01872507

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

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

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Key information

Conditions

Cerebral Palsy Autonomic Nerveus System Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, 91240, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback training

Other

usual treatment +12 biofeedback training

Primary outcomes

  1. Change from Baseline of Heart rate variability meaures at one and two months

    Time frame: Change from Baseline at one and two months

Secondary outcomes

  1. Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume,

    Time frame: Change from Baseline at one and two month

  2. Change from Baseline Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.

    Time frame: Change from baseline at one and two month later

  3. Change from baseline breathing rate, by biofeedback

    Time frame: Change from baseline at one and two month later

Other outcomes

  1. Change from baseline Gross Motor Function Measure

    Time frame: Change from baseline at one and two month later

  2. Change from baseline Children Assessment of Participation and Enjoyment

    Time frame: Change from baseline at one and two month later

  3. Change from baseline Autonomic function questionnaire

    Time frame: Change from baseline at one and two month later

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 7, 2013
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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