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

Cerebral Palsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872507
• Other study ID #: HMO-0374-12
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: February 27, 2018
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2018
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nerveus System
• Cerebral Palsy
• Paralysis

Intervention

Other:
• Biofeedback training
usual treatment +12 biofeedback training

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Ferreira MC, Pastore C, Imada R, Guaré R, Leite M, Poyares D, Santos MT. Autonomic nervous system in individuals with cerebral palsy: a controlled study. J Oral Pathol Med. 2011 Aug;40(7):576-81. doi: 10.1111/j.1600-0714.2011.01008.x. Epub 2011 Feb 16. — View Citation

Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. — View Citation

Sutarto AP, Wahab M, Zin NM. Heart Rate Variability (HRV),biofeedback; A new training approch for aperator's performance enhancement. JIEM, 2010, 3;176-198.

Zamunér AR, Cunha AB, da Silva E, Negri AP, Tudella E, Moreno MA. The influence of motor impairment on autonomic heart rate modulation among children with cerebral palsy. Res Dev Disabil. 2011 Jan-Feb;32(1):217-21. doi: 10.1016/j.ridd.2010.09.020. Epub 2010 Oct 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Gross Motor Function Measure		Change from baseline at one and two month later
Other	Change from baseline Children Assessment of Participation and Enjoyment		Change from baseline at one and two month later
Other	Change from baseline Autonomic function questionnaire		Change from baseline at one and two month later
Primary	Change from Baseline of Heart rate variability meaures at one and two months		Change from Baseline at one and two months
Secondary	Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume,		Change from Baseline at one and two month
Secondary	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
Secondary	Change from baseline breathing rate, by biofeedback		Change from baseline at one and two month later