Heart Rate Variability (HRV) Among Children With Brain Damage
This study has been terminated.
Sponsor:
Alyn Pediatric & Adolecent Rehabilitation Center
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
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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
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 Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013