The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children
April 12, 2010 updated by: Soroka University Medical Center
Children suffer from Cerebral Palsy that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 2 month after BOTOX injection in the movement and Rehabilitation Laboratory at BGU.
An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing.
These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins & De Luca, 1993).
Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions).
Participants will be required to stand on the platform 5 times for 30 s For each trial, they will be instructed to sway as little as possible.
In addition Gait analysis will be also examined.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beer-Sheva, Israel
- Soroka University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
30 children suffer from Cerbral Palsy
Description
Inclusion Criteria:
- Cerebral palsy
- BOTOX injection
Exclusion Criteria:
- Not able to stand independently 60 seconds
- Not able to walk independently
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
A
|
botox injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
SDF parameters
Time Frame: before and 2 months after the BOTOX injection
|
before and 2 months after the BOTOX injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
March 30, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 2, 2008
Study Record Updates
Last Update Posted (Estimate)
April 13, 2010
Last Update Submitted That Met QC Criteria
April 12, 2010
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- sor465708ctil
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.