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

Primary Purpose

Cerebral Palsy, Autonomic Nerveus System

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Biofeedback training

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, autonomic nerveus system, heart rate variability

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

biofeedback training

control

Arm Description

usual treatment+12 treatment of biofeedback training

usual treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Change from baseline breathing rate, by biofeedback

Full Information

NCT ID

NCT01872507

First Posted

May 1, 2013

Last Updated

February 27, 2018

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01872507

Brief Title

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

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

July 2013 (Actual)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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: 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy, Autonomic Nerveus System

Keywords

cerebral palsy, autonomic nerveus system, heart rate variability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

biofeedback training

Arm Type

Active Comparator

Arm Description

usual treatment+12 treatment of biofeedback training

Arm Title

control

Arm Type

No Intervention

Arm Description

usual treatment

Intervention Type

Other

Intervention Name(s)

Biofeedback training

Intervention Description

usual treatment +12 biofeedback training

Primary Outcome Measure Information:

Title

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

Time Frame

Change from Baseline at one and two months

Secondary Outcome Measure Information:

Title

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

Time Frame

Change from Baseline at one and two month

Title

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

Time Frame