Clinical trial NCT00358865: Checking the Usability of a Virtual Reality System in Children With Brain Injury
Official title: Checking the Usability of Video Projected Virtual Reality Sytem in Children With Acquired Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Brain Injury
Keywords: Virtual Reality
ABI
Projected system
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Tel Hashomer (THS) - Pediatric Rehabilitation Department
Study officials:
affiliation: Sheba Medical Center
name: amichay brezner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haifa university, OT Department
name: Tamar Weiss, prof.
role: STUDY_DIRECTOR
affiliation: Tel Aviv University, OT Department
name: Brat Orit, PhD
role: STUDY_DIRECTOR
References: