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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01335100

Enrollment

Registered

2011-04-14

Start date

2010-03-31

Completion date

Unknown

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Functional outcome, Quality of life, Global Positioning System (GPS), Advanced tracking technologies, Time-space activity., walking speed, distances, number of walking events and destinations

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
outdoor activity	9 months

Secondary

Measure	Time frame
leisure activity preferences and quality of life	9 months for the pilot

Countries

Israel

Outcome results