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
  Purpose

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.


Condition
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • outdoor activity [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • leisure activity preferences and quality of life [ Time Frame: 9 months for the pilot ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2010
Groups/Cohorts
ambulatory CP
ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs
controls
age and gender matched sibilings

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

ambulatory children with CP following BTX injection to the lower limbs

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01335100

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Hilla Ben Pazi, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01335100     History of Changes
Other Study ID Numbers: BTX-GPS
Study First Received: June 6, 2010
Last Updated: May 1, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
Functional outcome
Quality of life
Global Positioning System (GPS)
Advanced tracking technologies
Time-space activity.
walking speed
distances
number of walking events and destinations

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014