Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study
This trial is active, not recruiting.
|Sponsor||Shaare Zedek Medical Center|
|Start date||March 2010|
|Trial size||10 participants|
|Trial identifier||NCT01335100, BTX-GPS|
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.
To examine outdoor activity as a functional outcome following lower limb BTX in children with CP.
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.
|Observational model||case control|
ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs
age and gender matched sibilings
time frame: 9 months
leisure activity preferences and quality of life
time frame: 9 months for the pilot
Male or female participants from 5 years up to 18 years old.
Inclusion Criteria: - ambulatory children with CP following BTX injection to the lower limbs Exclusion Criteria: - significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces
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