NCT00746291

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

September 1, 2008

Last Update Submit

July 9, 2012

Conditions

Brain InjuryCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • HRV parameters

    during the assessment

Study Arms (3)

A

EXPERIMENTAL

Traumatic brain injury

Other: 6 min walk test, Step climbing

B

EXPERIMENTAL

Cerebral palsy

Other: 6 min walk test, Step climbing

C

EXPERIMENTAL

Controls

Other: 6 min walk test, Step climbing

Interventions

6 min walk test, Step climbingOTHER

walking for 6 minute and climbing steps

ABC

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • able to walk independently

You may not qualify if:

  • can not follow simple commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyn Pediatric and Adolescent Rehabilitation Center

Jerusalem, 91090, Israel

Location

MeSH Terms

Conditions

Brain InjuriesCerebral Palsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain Damage, Chronic

Study Officials

  • Hemda Rotem

    Alyn Hopspital Jerusalem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 3, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

IL(1)