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)
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00651339
First received: March 30, 2008
Last updated: April 12, 2010
Last verified: February 2008
  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:


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 April 15, 2014