Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study
NCT ID: NCT01335100
Last Updated: 2011-05-03
Study Results
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Basic Information
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UNKNOWN
10 participants
OBSERVATIONAL
2010-03-31
Brief Summary
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Motor impairment limits social and recreational activities in children with cerebral palsy (CP), compromising participation and impacting on quality of life. Improvement of motor function by medical treatment may advance in participation of outdoor activities and expand social and recreational activities. While Botulinum toxin (BTX) injections are effective and safe treatment for spasticity in children with CP, there is insufficient evidence for improvement of motor function and enhanced participation in this population.
Objective:
To examine outdoor activity as a functional outcome following lower limb BTX in children with CP.
Methods:
In this pilot study the investigators will use Global Positioning Systems (GPS) to measure walking speed, distances, number of walking events and destinations in ambulatory children with CP following BTX injection to the lower limbs; age and gender matched sibling will be studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be correlated with leisure activity preferences and quality of life questionnaires.
Significance: Improvement in outdoor activity following BTX injections in this pilot study will assist construction of a larger study evaluating participation and quality of life in children with CP.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ambulatory CP
ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs
No interventions assigned to this group
controls
age and gender matched sibilings
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
18 Years
ALL
Yes
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Shaare Zedek Medical Center
Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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BTX-GPS
Identifier Type: -
Identifier Source: org_study_id
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