The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury

NCT ID: NCT02627651

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Brain Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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brain injury

children post brain injury

Group Type EXPERIMENTAL

cognitive and motor assignments

Intervention Type OTHER

walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .

controls

children typically developed age matched

Group Type ACTIVE_COMPARATOR

cognitive and motor assignments

Intervention Type OTHER

walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .

Interventions

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cognitive and motor assignments

walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

aged 10-18 understand simple commands walk independently

Exclusion Criteria

Canot understand simple commands
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alyn Pediatric & Adolescent Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alyn Pediatric and Adolesencent Rehabilitation Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Alyn

Identifier Type: -

Identifier Source: org_study_id

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