Checking the Usability of a Virtual Reality System in Children With Brain Injury
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | July 31, 2006 | ||||||||||||
| Last Updated Date | April 30, 2008 | ||||||||||||
| Start Date ICMJE | December 2005 | ||||||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00358865 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Checking the Usability of a Virtual Reality System in Children With Brain Injury | ||||||||||||
| Official Title ICMJE | Checking the Usability of Video Projected Virtual Reality Sytem in Children With Acquired Brain Injury | ||||||||||||
| Brief Summary | 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)and comparing their performance to the performance of normally developing children. The trial shall include 15 subjects in each group, aged 6-12 years old. ABI subjects are hospitalized at the 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 different attention abilities. Performance correlations will be tested between these tests and the performance in the VR first experience. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | The study sample consisted of 33 children, and was divided into study and control groups: 16 children with ABI from the Pediatric Rehabilitation department at the Sheba Medical Center, Tel Hashomer in the study group (mean age = 7.91, S.D. = 1.43, range from 6 to 11.4 years old), and 17 healthy participants in the control group (mean age = 7.94, S.D. = 1.57, range from 6 - 11.33 years). |
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| Condition ICMJE | Acquired Brain Injury | ||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||||||
| Completion Date | December 2006 | ||||||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:(trial group)
Exclusion Criteria: (trial group)
Inclusion Criteria (control group):
Exclusion Criteria (control group):
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| Gender | Both | ||||||||||||
| Ages | 6 Years to 12 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00358865 | ||||||||||||
| Other Study ID Numbers ICMJE | SHEBA-05-3847-AB-CTIL | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | Sheba Medical Center | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Sheba Medical Center | ||||||||||||
| Verification Date | April 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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