ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00651339
Recruitment Status : Terminated (recruiting or enrolling participants has halted prematurely and will not resume)
First Posted : April 2, 2008
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
Soroka University Medical Center

Brief Summary:
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 or disease Intervention/treatment
Cerebral Palsy Drug: botox

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : February 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A Drug: botox
botox injection




Primary Outcome Measures :
  1. SDF parameters [ Time Frame: before and 2 months after the BOTOX injection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651339


Locations
Israel
Soroka University Medical Center
Beer-Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center

Responsible Party: Itshak Melzer PhD, PT, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00651339     History of Changes
Other Study ID Numbers: sor465708ctil
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: February 2008

Keywords provided by Soroka University Medical Center:
Cerebral Palsy
Balance
Gait

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs