Checking the Usability of a Virtual Reality System in Children With Brain Injury

Acquired Brain Injury Clinical Trial

Official title:

Checking the Usability of Video Projected Virtual Reality Sytem in Children With Acquired Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358865
• Other study ID #: SHEBA-05-3847-AB-CTIL
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2006
• Last updated: April 30, 2008
• Start date: December 2005
• Est. completion date: December 2006

Study information

• Verified date: April 2008
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

Locations

Country	Name	City	State
Israel	Tel Hashomer (THS) - Pediatric Rehabilitation Department	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,