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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)
Information provided by:
Soroka University Medical Center Identifier:
First received: March 30, 2008
Last updated: April 12, 2010
Last verified: February 2008
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:

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 ]

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


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

Inclusion Criteria:

  • Cerebral palsy
  • BOTOX injection

Exclusion Criteria:

  • Not able to stand independently 60 seconds
  • Not able to walk independently
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00651339

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

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

Keywords provided by Soroka University Medical Center:
Cerebral Palsy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on September 19, 2017