Back to resultsHeart Rate Variability (HRV) Among Children With Brain Damage
Primary Purpose
Brain Injury, Cerebral Palsy
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
6 min walk test, Step climbing
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury
Eligibility Criteria
Inclusion Criteria:
- able to walk independently
Exclusion Criteria:
- can not follow simple commands
Sites / Locations
- Alyn Pediatric and Adolescent Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A
B
C
Arm Description
Traumatic brain injury
Cerebral palsy
Controls
Outcomes
Primary Outcome Measures
HRV parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT00746291
First Posted
September 1, 2008
Last Updated
July 9, 2012
Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00746291
Brief Title
Heart Rate Variability (HRV) Among Children With Brain Damage
Official Title
Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Traumatic brain injury
Arm Title
B
Arm Type
Experimental
Arm Description
Cerebral palsy
Arm Title
C
Arm Type
Experimental
Arm Description
Controls
Intervention Type
Other
Intervention Name(s)
6 min walk test, Step climbing
Intervention Description
walking for 6 minute and climbing steps
Primary Outcome Measure Information:
Title
HRV parameters
Time Frame
during the assessment
10. Eligibility
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
able to walk independently
Exclusion Criteria:
can not follow simple commands
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hemda Rotem
Organizational Affiliation
Alyn Hopspital Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alyn Pediatric and Adolescent Rehabilitation Center
City
Jerusalem
ZIP/Postal Code
91090
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Heart Rate Variability (HRV) Among Children With Brain Damage
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