Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Shaare Zedek Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01335100
First received: June 6, 2010
Last updated: May 1, 2011
Last verified: May 2011

June 6, 2010
May 1, 2011
March 2010
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outdoor activity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01335100 on ClinicalTrials.gov Archive Site
leisure activity preferences and quality of life [ Time Frame: 9 months for the pilot ] [ Designated as safety issue: No ]
Same as current
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Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study
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Background:

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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

ambulatory children with CP following BTX injection to the lower limbs

Cerebral Palsy
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  • ambulatory CP
    ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs
  • controls
    age and gender matched sibilings
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
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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
Both
5 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01335100
BTX-GPS
Not Provided
Hilla Ben Pazi, MD, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
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Shaare Zedek Medical Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP