- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02627651
The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
July 18, 2016 updated by: Alyn Pediatric & Adolescent Rehabilitation Hospital
The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
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
-
-
-
Jerusalem, Israel, 91090
- Alyn Pediatric and Adolesencent 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
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
aged 10-18 understand simple commands walk independently
Exclusion Criteria:
Canot understand 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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: brain injury
children post brain injury
|
walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .
|
Active Comparator: controls
children typically developed age matched
|
walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate
Time Frame: 5 min
|
5 min
|
Heart rate variability- time domain measures
Time Frame: 5 min
|
5 min
|
Heart rate variability- frequency domain measures
Time Frame: 5 min
|
5 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
December 2, 2015
First Submitted That Met QC Criteria
December 9, 2015
First Posted (Estimate)
December 11, 2015
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
July 18, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alyn
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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