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Heart Rate Variability (HRV) Among Children With Brain Damage

NCT ID: NCT00746291

Last Updated: 2012-07-10

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

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (HRV) occurring with walking performance.

Detailed Description

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40 children with brain damage (20 with post TBI and 20 with CP)and 40 typically developed children will be participate in this study. ECG signals during rest and walking (for 6 minute and during step climbing) will be recorded.

Conditions

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Brain Injury Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Traumatic brain injury

Group Type EXPERIMENTAL

6 min walk test, Step climbing

Intervention Type OTHER

walking for 6 minute and climbing steps

B

Cerebral palsy

Group Type EXPERIMENTAL

6 min walk test, Step climbing

Intervention Type OTHER

walking for 6 minute and climbing steps

C

Controls

Group Type EXPERIMENTAL

6 min walk test, Step climbing

Intervention Type OTHER

walking for 6 minute and climbing steps

Interventions

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6 min walk test, Step climbing

walking for 6 minute and climbing steps

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* able to walk independently

Exclusion Criteria

* can not follow simple commands
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

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

Principal Investigators

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Hemda Rotem

Role: PRINCIPAL_INVESTIGATOR

Alyn Hopspital Jerusalem

Locations

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Alyn Pediatric and Adolescent Rehabilitation Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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alyn3CTIL

Identifier Type: -

Identifier Source: org_study_id