Heart Rate Variability (HRV) Among Children With Brain Damage

July 9, 2012 updated by: Alyn Pediatric & Adolescent Rehabilitation Hospital

Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91090
        • Alyn Pediatric and Adolescent Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • able to walk independently

Exclusion Criteria:

  • can not follow simple commands

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HRV parameters
Time Frame: during the assessment
during the assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alyn Pediatric & Adolescent Rehabilitation Hospital

Investigators

  • Principal Investigator: Hemda Rotem, Alyn Hopspital Jerusalem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • alyn3CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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