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

• Conditions: Cerebral Palsy

• Registration Number: NCT01335100
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-06
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-14
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-01
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
outdoor activity	9 months

Secondary Outcome Measures

Name	Time	Method
leisure activity preferences and quality of life	9 months for the pilot

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel