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Heart Rate Variability (HRV) Among Children With Brain Damage

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ClinicalTrials.gov Identifier: NCT00746291
Recruitment Status : Terminated
First Posted : September 3, 2008
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alyn Pediatric & Adolecent Rehabilitation Center

Brief Summary:
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 or disease Intervention/treatment Phase
Brain Injury Cerebral Palsy Other: 6 min walk test, Step climbing Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.
Study Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. HRV parameters [ Time Frame: during the assessment ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • able to walk independently

Exclusion Criteria:

  • can not follow simple commands

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alyn Pediatric & Adolecent Rehabilitation Center
ClinicalTrials.gov Identifier: NCT00746291     History of Changes
Other Study ID Numbers: alyn3CTIL
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

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