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
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 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 August 21, 2014