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

February 27, 2018 updated by: BERGER ITAI, Hadassah Medical Organization

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91240
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: biofeedback training
usual treatment+12 treatment of biofeedback training
Other: Biofeedback training
usual treatment +12 biofeedback training
NO_INTERVENTION: control
usual treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume,
Time Frame: Change from Baseline at one and two month
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.
Time Frame: Change from baseline at one and two month later
Change from baseline at one and two month later
Change from baseline breathing rate, by biofeedback
Time Frame: Change from baseline at one and two month later
Change from baseline at one and two month later

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline Gross Motor Function Measure
Time Frame: Change from baseline at one and two month later
Change from baseline at one and two month later
Change from baseline Children Assessment of Participation and Enjoyment
Time Frame: Change from baseline at one and two month later
Change from baseline at one and two month later
Change from baseline Autonomic function questionnaire
Time Frame: Change from baseline at one and two month later
Change from baseline at one and two month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2013

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (ESTIMATE)

June 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMO-0374-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Biofeedback training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe