This trial is active, not recruiting.

Condition cerebral palsy
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs
age and gender matched sibilings

Primary Outcomes

outdoor activity
time frame: 9 months

Secondary Outcomes

leisure activity preferences and quality of life
time frame: 9 months for the pilot

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Shaare Zedek Medical Center.