The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury

Brain Injuries Clinical Trial

Official title:

The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627651
• Other study ID #: Alyn
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: July 18, 2016
• Start date: January 2015

Study information

• Verified date: July 2016
• Source: Alyn Pediatric & Adolecent Rehabilitation Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

aged 10-18 understand simple commands walk independently

Exclusion Criteria:

Canot understand simple commands

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Other:
• cognitive and motor assignments
walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .

Locations

Country	Name	City	State
Israel	Alyn Pediatric and Adolesencent Rehabilitation Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Alyn Pediatric & Adolecent Rehabilitation Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate		5 min	No
Primary	Heart rate variability- time domain measures		5 min	No
Primary	Heart rate variability- frequency domain measures		5 min	No