Cerebral PalsyNCT00651339
The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children
An observational study of Cerebral Palsy, run by Soroka University Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- botox
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: 30 children suffer from Cerbral Palsy
Who may be able to join
- Cerebral palsy
- BOTOX injection
Who cannot join
- Not able to stand independently 60 seconds
- Not able to walk independently
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Palsy
- Being tested
- botox
- Keywords
- Cerebral Palsy, Balance, Gait
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botoxDrug
botox injection
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDF parameters
Measured: before and 2 months after the BOTOX injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionJun 2009
Why it stopped: recruiting or enrolling participants has halted prematurely and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651339
- Sponsor's protocol ID
- sor465708ctil
- Status last verified
- Feb 2008
- First submitted
- 30 Mar 2008
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children
- ClinicalTrials.gov ID
- NCT00651339
- Acronym / sponsor ID
- sor465708ctil
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Balance, Gait
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruiting or enrolling participants has halted prematurely and will not resume
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: botox |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 30 children suffer from Cerbral Palsy
Key inclusion criteria (2 listed)
- Cerebral palsy
- BOTOX injection
Key exclusion criteria (2 listed)
- Not able to stand independently 60 seconds
- Not able to walk independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botoxbotox injection | Drug | A |
Primary outcome
SDF parameters
Time frame: before and 2 months after the BOTOX injection
Results and safety
The study was stopped early (reason given: recruiting or enrolling participants has halted prematurely and will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruiting or enrolling participants has halted prematurely and will not resume). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDF parameters (time frame: before and 2 months after the BOTOX injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2010.