- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01840644
Validity and Reliability of Perceived Exertion Rating Scale in Children With Brain Damage
June 22, 2015 updated by: Alyn Pediatric & Adolescent Rehabilitation Hospital
Validity and Reliability of Perceived Exertion Rating Scale in Children With Traumatic Brain Injury, Cerebral Palsy and Typically Developed
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
walking on a treadmill twice- one weeks interval five intensity level in each session
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jerusalem, Israel, 91090
- Alyn Children's Rehabilitation Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children post severe TBI Children with CP TD control
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
- Cannot understand simple instructions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
all participants
Walking on treadmill, different velocities and incline
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Walking on treadmill twice, with one week interval in each session the child will walk in different velocities and incline
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
OMNI scale, a pictorial perceived extortion scale for children
Time Frame: three meetings once a week.
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three meetings once a week.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Michal Katz, Phd, Alyn rehabilitation center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
February 15, 2010
First Submitted That Met QC Criteria
April 23, 2013
First Posted (Estimate)
April 26, 2013
Study Record Updates
Last Update Posted (Estimate)
June 23, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 920090351
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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