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:

  1. Heart rate monitor
  2. Six minute walk test
  3. The behavior rating inventory

Method:

  1. 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.
  2. 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

  • Israel
      • 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
Other: cognitive and motor assignments
walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .
Active Comparator: controls
children typically developed age matched
Other: cognitive and motor assignments
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.

Sponsor

Alyn Pediatric & Adolescent Rehabilitation Hospital

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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