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

NCT01872507 | Completed DMC

• 1 other identifier: HMO-0374-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.
2. 2.Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.
3. 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

Conditions

Cerebral Palsy; Autonomic Nerveus System

Keywords

cerebral palsy; autonomic nerveus system; heart rate variability

Outcome Measures

Primary Outcomes (1)

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

  Change from Baseline at one and two months

Secondary Outcomes (3)

• 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 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 breathing rate, by biofeedback

  Change from baseline at one and two month later

Other Outcomes (3)

• Change from baseline Gross Motor Function Measure

  Change from baseline at one and two month later

• Change from baseline Children Assessment of Participation and Enjoyment

  Change from baseline at one and two month later

• Change from baseline Autonomic function questionnaire

  Change from baseline at one and two month later

Study Arms (2)

biofeedback training

ACTIVE COMPARATOR

usual treatment+12 treatment of biofeedback training

Other: Biofeedback training

control

NO INTERVENTION

usual treatment

Interventions

Biofeedback training OTHER

usual treatment +12 biofeedback training

biofeedback training

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with cerebral palsy
• age 6-11 years
• able to walk
• both gender

You may not qualify if:

• heart or lung known disease
• can not follow simple commends

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91240, Israel

Location

Related Publications (4)

• Zamuner 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.

  PMID: 20956067 BACKGROUND

• 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.

  BACKGROUND

• Ferreira MC, Pastore C, Imada R, Guare 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.

  PMID: 21323740 BACKGROUND

• 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. doi: 10.1023/a:1009554825745.

  PMID: 10999236 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Itai Berger, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Neuro-Cognitive Center Pediatric Wing

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: June 7, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

IL (1)