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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
BERGER ITAI, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01872507
First received: May 1, 2013
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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

Condition Intervention
Cerebral Palsy
Autonomic Nerveus System
Other: Biofeedback training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Change from Baseline of Heart rate variability meaures at one and two months [ Time Frame: Change from Baseline at one and two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume, [ Time Frame: Change from Baseline at one and two month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline breathing rate, by biofeedback [ Time Frame: Change from baseline at one and two month later ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline Gross Motor Function Measure [ Time Frame: Change from baseline at one and two month later ] [ Designated as safety issue: No ]
  • Change from baseline Children Assessment of Participation and Enjoyment [ Time Frame: Change from baseline at one and two month later ] [ Designated as safety issue: No ]
  • Change from baseline Autonomic function questionnaire [ Time Frame: Change from baseline at one and two month later ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: biofeedback training
usual treatment+12 treatment of biofeedback training
Other: Biofeedback training
usual treatment +12 biofeedback training
No Intervention: control
usual 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
  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872507

Contacts
Contact: Itai Berger, MD 97225844903 itberg@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91240
Contact: Taly Amichai, BPT MsSc    97289257319    taly.amichai@gmail.com   
Sub-Investigator: Sagi Gavri, MD         
Sub-Investigator: Avraham Weiss, MD         
Sub-Investigator: Taly Amichai, BPT Msc         
Sub-Investigator: Michal Katz-Leurer, PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Itai Berger, MD Hadassah Medical Organization
  More Information

Publications:
Responsible Party: BERGER ITAI, Director Neuro-Cognitive Center Pediatric Wing, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01872507     History of Changes
Other Study ID Numbers: HMO-0374-12
Study First Received: May 1, 2013
Last Updated: June 5, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
cerebral palsy
autonomic nerveus system
heart rate variability

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014