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Heart Rate Variability (HRV) Among Children With Brain Damage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 & Adolescent Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2008
First Posted Date  ICMJE September 3, 2008
Last Update Posted Date July 10, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
HRV parameters [ Time Frame: during the assessment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Rate Variability (HRV) Among Children With Brain Damage
Official Title  ICMJE Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Injury
  • Cerebral Palsy
Intervention  ICMJE Other: 6 min walk test, Step climbing
walking for 6 minute and climbing steps
Study Arms  ICMJE
  • Experimental: A
    Traumatic brain injury
    Intervention: Other: 6 min walk test, Step climbing
  • Experimental: B
    Cerebral palsy
    Intervention: Other: 6 min walk test, Step climbing
  • Experimental: C
    Controls
    Intervention: Other: 6 min walk test, Step climbing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2008)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • able to walk independently

Exclusion Criteria:

  • can not follow simple commands
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746291
Other Study ID Numbers  ICMJE alyn3CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alyn Pediatric & Adolescent Rehabilitation Hospital
Study Sponsor  ICMJE Alyn Pediatric & Adolescent Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hemda Rotem Alyn Hopspital Jerusalem
PRS Account Alyn Pediatric & Adolescent Rehabilitation Hospital
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP