Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01335100|
Recruitment Status : Unknown
Verified May 2011 by Shaare Zedek Medical Center.
Recruitment status was: Active, not recruiting
First Posted : April 14, 2011
Last Update Posted : May 3, 2011
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Observational Model:||Case Control|
|Study Start Date :||March 2010|
ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs
age and gender matched sibilings
- outdoor activity [ Time Frame: 9 months ]
- leisure activity preferences and quality of life [ Time Frame: 9 months for the pilot ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335100
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|