Back to resultsThe Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
Primary Purpose
Brain Injuries
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
cognitive and motor assignments
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Injuries
Eligibility Criteria
Inclusion Criteria:
aged 10-18 understand simple commands walk independently
Exclusion Criteria:
Canot understand simple commands
Sites / Locations
- Alyn Pediatric and Adolesencent Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
brain injury
controls
Arm Description
children post brain injury
children typically developed age matched
Outcomes
Primary Outcome Measures
Heart rate
Heart rate variability- time domain measures
Heart rate variability- frequency domain measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02627651
First Posted
December 2, 2015
Last Updated
July 18, 2016
Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02627651
Brief Title
The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
Official Title
The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
4. Oversight
5. Study Description
Brief Summary
18 children post acquired brain injury and 18 typically developed controls matched for age and gender.
All children aged 10-18 yrs who understand simple commands.
Tools:
Heart rate monitor
Six minute walk test
The behavior rating inventory
Method:
At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds.
At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brain injury
Arm Type
Experimental
Arm Description
children post brain injury
Arm Title
controls
Arm Type
Active Comparator
Arm Description
children typically developed age matched
Intervention Type
Other
Intervention Name(s)
cognitive and motor assignments
Intervention Description
walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .
Primary Outcome Measure Information:
Title
Heart rate
Time Frame
5 min
Title
Heart rate variability- time domain measures
Time Frame
5 min
Title
Heart rate variability- frequency domain measures
Time Frame
5 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 10-18 understand simple commands walk independently
Exclusion Criteria:
Canot understand simple commands
Facility Information:
Facility Name
Alyn Pediatric and Adolesencent Rehabilitation Center
City
Jerusalem
ZIP/Postal Code
91090
Country
Israel
12. IPD Sharing Statement
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The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
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