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

Not Applicable

Completed

• Conditions: Cerebral Palsy; Autonomic Nerveus System
• Interventions: Other: Biofeedback training

• Registration Number: NCT01872507
• Lead Sponsor: Hadassah Medical Organization

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:

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

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 Timeline

• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Study Start: 2013-07
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biofeedback training	Biofeedback training	usual treatment+12 treatment of biofeedback training

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume,	Change from Baseline at one and two month
Change from baseline breathing rate, by biofeedback	Change from baseline at one and two month later

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel