Brain InjuriesNCT00425958
Examination of Virtual Supermarket (Vmall) as an Assessment of Executive Functions in Children and Adolescents With Acquired Brain Injury
An observational study of Brain Injuries, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this research is to find whether or not there are differences in the executive functions during "shopping" in a "virtual mall", between children with Acquired Brain Injury (ABI) vs healthy children. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2006to Sep 2006
- 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with ABI
- at least a year after injury
- who have been discharged from hospital and back home
Who cannot join
- children with learning disabilities former to injury
- visual disabilities or developmental disabilities
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to find whether or not there are differences in the executive functions during "shopping" in a "virtual mall", between children with Acquired Brain Injury (ABI) vs healthy children.
The hypothesis is that there will be differences in time (more time to shop) and mistakes (more mistakes during shopping), in the ABI group.
- Conditions
- Brain Injuries
- Keywords
- year and more after TBI, good vision, at least one functinal hand, cap[able od doing shopping during everyday life
- Medical subject headings
- Brain Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startApr 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Amichai Brezner, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425958
- Sponsor's protocol ID
- SHEBA-05-3856-AB-CTIL
- Status last verified
- Sep 2007
- First submitted
- 23 Jan 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Virtual Supermarket (Vmall) as an Assessment of Executive Functions in Children and Adolescents With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT00425958
- Acronym / sponsor ID
- SHEBA-05-3856-AB-CTIL
- Conditions
- Brain Injuries
- Keywords
- year and more after TBI, good vision, at least one functinal hand, cap[able od doing shopping during everyday life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Jan 2007 (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.
The purpose of this research is to find whether or not there are differences in the executive functions during "shopping" in a "virtual mall", between children with Acquired Brain Injury (ABI) vs healthy children.
The hypothesis is that there will be differences in time (more time to shop) and mistakes (more mistakes during shopping), in the ABI group.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with ABI
- at least a year after injury
- who have been discharged from hospital and back home
Key exclusion criteria (2 listed)
- children with learning disabilities former to injury
- visual disabilities or developmental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2007.
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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.
Amichai Brezner, MD principal investigator
Sheba Medical Center
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 Brain Injuries, run by Sheba 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 3 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: finished, as of the sponsor's last update on 26 Sep 2007. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 26 Sep 2007.