- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839369
Walking Dynamic Among Children With Brain Damge
July 20, 2016 updated by: Alyn Pediatric & Adolescent Rehabilitation Hospital
The Effect of Changing Walking Conditions on Walking Dynamic Characteristics Among Children Post a Severe Traumatic Brain Injury, Cerebral Palsy and Typically Developed (TD) Control.
The goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
leisure time physical activity by the Godin and Shephard (G&S) questionnaire.
Balance tests - the Timed Up and Go test (TUG) and functional reach test (FRT).
Maximal isometric strength was assessed by using a hand held dynamometer; walking dynamics were recorded by an electronic mat, and the 6 minute walk test, energy expenditure index (EEI) and perceived exertion by the OMNI scale.
Study Type
Observational
Enrollment (Actual)
45
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 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children post Traumatic Brain Injury with Cerebral palsy Typically Developed
Description
Inclusion Criteria:
Post Traumatic Brain Injury
- 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 13 years
- Independent ambulation (foot orthoses permitted)
Children with Cerebral palsy
- GMFCS 1 or 2
- Ages 7 to 13 years
- Able to stand up from a chair independently and maintain standing for more than 5 seconds without falling, without obvious limitation in the passive range of motion of lower extremities.
Typically Developed age and sex controls exclusion criteria:
- Children who could not fulfill 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 |
|---|---|
|
children
post Traumatic Brain Injury With Cerebral Palsy Typically developed
|
The children were asked to walk an electronic mat, three cycles for each one of the different trials as comfortable regular speed, walking as fast and as slow as possible, walking on straight line etc
walking on electronic walkway under different conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
step characteristics
Time Frame: 30 minutes
|
The Gaitrite system - step length and time variability (%).
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
step time
Time Frame: part of the first assessment
|
step time in sec
|
part of the first assessment
|
|
step length
Time Frame: part of the first assessment
|
step length in cm
|
part of the first assessment
|
|
gait velocity
Time Frame: part of the first assessment
|
walking velocity (cm/sec),
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part of the first assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
April 1, 2009
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
February 28, 2010
First Submitted That Met QC Criteria
July 20, 2016
First Posted (Estimate)
July 21, 2016
Study Record Updates
Last Update Posted (Estimate)
July 21, 2016
Last Update Submitted That Met QC Criteria
July 20, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 158-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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