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

Cerebral Palsy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00651339
• Other study ID #: sor465708ctil
• Status: Terminated
• Phase: N/A
• First received: March 30, 2008
• Last updated: April 12, 2010
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2008
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• Cerebral palsy

• BOTOX injection

Exclusion Criteria:

• Not able to stand independently 60 seconds

• Not able to walk independently

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Drug:
• botox
botox injection

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SDF parameters		before and 2 months after the BOTOX injection	No