NCT01335100

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
Last Updated

May 3, 2011

Status Verified

May 1, 2011

First QC Date

June 6, 2010

Last Update Submit

May 1, 2011

Conditions

Cerebral Palsy

Keywords

Functional outcomeQuality of lifeGlobal Positioning System (GPS)Advanced tracking technologiesTime-space activity.walking speeddistancesnumber of walking events and destinations

Outcome Measures

Primary Outcomes (1)

  • outdoor activity

    9 months

Secondary Outcomes (1)

  • leisure activity preferences and quality of life

    9 months for the pilot

Study Arms (2)

ambulatory CP

ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs

controls

age and gender matched sibilings

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ambulatory children with CP following BTX injection to the lower limbs

You may qualify if:

  • ambulatory children with CP following BTX injection to the lower limbs

You may not qualify if:

  • significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2010

First Posted

April 14, 2011

Study Start

March 1, 2010

Last Updated

May 3, 2011

Record last verified: 2011-05

Locations

IL(1)