Heart Rate Variability (HRV) Among Children With Brain Damage

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Alyn Pediatric & Adolecent Rehabilitation Center
ClinicalTrials.gov Identifier:
NCT00746291
First received: September 1, 2008
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (HRV) occurring with walking performance.


Condition Intervention
Brain Injury
Cerebral Palsy
Other: 6 min walk test, Step climbing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.

Resource links provided by NLM:


Further study details as provided by Alyn Pediatric & Adolecent Rehabilitation Center:

Primary Outcome Measures:
  • HRV parameters [ Time Frame: during the assessment ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Traumatic brain injury
Other: 6 min walk test, Step climbing
walking for 6 minute and climbing steps
Experimental: B
Cerebral palsy
Other: 6 min walk test, Step climbing
walking for 6 minute and climbing steps
Experimental: C
Controls
Other: 6 min walk test, Step climbing
walking for 6 minute and climbing steps

Detailed Description:

40 children with brain damage (20 with post TBI and 20 with CP)and 40 typically developed children will be participate in this study. ECG signals during rest and walking (for 6 minute and during step climbing) will be recorded.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • able to walk independently

Exclusion Criteria:

  • can not follow simple commands
  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: NCT00746291

Locations
Israel
Alyn Pediatric and Adolescent Rehabilitation Center
Jerusalem, Israel, 91090
Sponsors and Collaborators
Alyn Pediatric & Adolecent Rehabilitation Center
Investigators
Principal Investigator: Hemda Rotem Alyn Hopspital Jerusalem
  More Information

No publications provided

Responsible Party: Alyn Pediatric & Adolecent Rehabilitation Center
ClinicalTrials.gov Identifier: NCT00746291     History of Changes
Other Study ID Numbers: alyn3CTIL
Study First Received: September 1, 2008
Last Updated: July 9, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Cerebral Palsy
Brain Injuries
Wounds and Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 31, 2014