The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children

This study has been terminated.

( recruiting or enrolling participants has halted prematurely and will not resume )

First Received on March 30, 2008. Last Updated on April 12, 2010 History of Changes

Sponsor:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00651339

Purpose

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.

Condition	Intervention
Cerebral Palsy	Drug: botox

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Botox Cerebral Palsy Paralysis

Drug Information available for: Botulinum toxin A

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

SDF parameters [ Time Frame: before and 2 months after the BOTOX injection ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Study Completion Date:	June 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: botox botox injection

Eligibility

Ages Eligible for Study:	3 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

30 children suffer from Cerbral Palsy

Criteria

Inclusion Criteria:

Cerebral palsy
BOTOX injection

Exclusion Criteria:

Not able to stand independently 60 seconds
Not able to walk independently

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651339

Locations

Israel
Soroka University Medical Center
Beer-Sheva, Israel

Sponsors and Collaborators

Soroka University Medical Center

More Information

No publications provided

Responsible Party:	Itshak Melzer PhD, PT, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:	NCT00651339 History of Changes
Other Study ID Numbers:	sor465708ctil
Study First Received:	March 30, 2008
Last Updated:	April 12, 2010
Health Authority:	Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:

Cerebral Palsy
Balance
Gait

Additional relevant MeSH terms:

Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012