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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. 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
Information provided by:
Shaare Zedek Medical Center

Brief Summary:


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
Cerebral Palsy

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : March 2010

Resource links provided by the National Library of Medicine

ambulatory CP
ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs
age and gender matched sibilings

Primary Outcome Measures :
  1. outdoor activity [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. leisure activity preferences and quality of life [ Time Frame: 9 months for the pilot ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ambulatory children with CP following BTX injection to the lower limbs

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01335100

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Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center

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Responsible Party: Hilla Ben Pazi, MD, Shaare Zedek Medical Center Identifier: NCT01335100     History of Changes
Other Study ID Numbers: BTX-GPS
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011
Keywords provided by Shaare Zedek Medical Center:
Functional outcome
Quality of life
Global Positioning System (GPS)
Advanced tracking technologies
Time-space activity.
walking speed
number of walking events and destinations
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs