- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358865
Checking the Usability of a Virtual Reality System in Children With Brain Injury
Checking the Usability of Video Projected Virtual Reality Sytem in Children With Acquired Brain Injury
Study Overview
Status
Conditions
Detailed Description
The purpose of this study is to check the usability of Virtual Reality (VR) Video Capture Projected System in children with acquired brain injury(ABI) comparing their performance with the performance of normally developing children, matched by age, gender,sector and parents' education. subjects' age: 6 - 12 years old. The trial shall include 15 subjects in each group. ABI subjects are hospitalized at Sheba Hospital's Pediatric Rehabilitation Department.
Each subject will experience 3 different virtual environments. The subjects in the trial group will practice 3 experiences (3 times in 3 different days) during a period of a week to 10 days, to check the practice effect. In addition, all subjects will be tested in three tests: "PEDI" - to evaluate the functional abilities of daily living (dressing, eating...),The "Melbourne Assessment" - to evaluate functional movements of upper extremities, and the TEA-ch - to evaluate difference attention abilities.
Correlations between those tests to the performance in the VR experiences will be checked with Pearson's statistical correlation tests. The differences between the trial group (ABI children) and the control group will be checked with Independent t-tests.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ramat Gan, Israel
- Tel Hashomer (THS) - Pediatric Rehabilitation Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:(trial group)
- acquired brain injury as a result of brain tumor excision intervention, traumatic brain injury, infection, vascular disorders, metabolic disorders or anoxia.
- ability to move at least one of the upper extremities against gravity in a partial range of motion (MMT: -3)
Exclusion Criteria: (trial group)
- Significant visual limitations
- Premorbid, progressive mental disorder or neurological injury
- Premorbid learning disability
Inclusion Criteria (control group):
- healthy subjects
Exclusion Criteria (control group):
- developmental disorders
- significant medical problems
- neurological disorders
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: amichay brezner, PhD, Sheba Medical Center
- Study Director: Tamar Weiss, prof., Haifa university, OT Department
- Study Director: Brat Orit, PhD, Tel Aviv University, OT Department
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-05-3847-AB-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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