NCT00651339

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 13, 2010

Status Verified

February 1, 2008

Enrollment Period

1 year

First QC Date

March 30, 2008

Last Update Submit

April 12, 2010

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyBalanceGait

Outcome Measures

Primary Outcomes (1)

  • SDF parameters

    before and 2 months after the BOTOX injection

Study Arms (1)

A

Drug: botox

Interventions

botoxDRUG

botox injection

A

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

30 children suffer from Cerbral Palsy

You may qualify if:

  • Cerebral palsy
  • BOTOX injection

You may not qualify if:

  • Not able to stand independently 60 seconds
  • Not able to walk independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 2, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2009

Study Completion

June 1, 2009

Last Updated

April 13, 2010

Record last verified: 2008-02

Locations

IL(1)