NCT01840644

Brief Summary

The purpose of this study is to examine the reliability and validity of the rating of perceived exertion scale in children post severe traumatic brain injury during treadmill exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 15, 2010

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

February 15, 2010

Last Update Submit

June 22, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • OMNI scale, a pictorial perceived extortion scale for children

    three meetings once a week.

Study Arms (1)

all participants

Walking on treadmill, different velocities and incline

Other: Walking on treadmill, different velocities and incline

Interventions

Walking on treadmill twice, with one week interval in each session the child will walk in different velocities and incline

Also known as: RPE
all participants

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children post severe TBI Children with CP TD control

You may qualify if:

  • Children post severe closed head injury (Glasgow Coma Scale \[GCS\] score at admission to emergency room of ≤8, at least one year post trauma
  • Ages 7 to 12 years
  • (3) independent ambulation (foot orthoses permitted).
  • Children with Cerebral palsy, GMFCS 1 or 2, ages 7 to 12 years. Typically developed controls.

You may not qualify if:

  • Cannot understand simple instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyn Children's Rehabilitation Hospital

Jerusalem, 91090, Israel

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticCerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michal Katz, Phd

    Alyn rehabilitation center

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2010

First Posted

April 26, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations