- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Ramat Gan, Israel
- Tel Hashomer (THS) - Pediatric Rehabilitation Department
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: amichay brezner, PhD, Sheba Medical Center
- Studieleder: Tamar Weiss, prof., Haifa university, OT Department
- Studieleder: Brat Orit, PhD, Tel Aviv University, OT Department
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHEBA-05-3847-AB-CTIL
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