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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00358865
First received: July 31, 2006
Last updated: April 30, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Phase
Acquired Brain Injury
 Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Checking the Usability of Video Projected Virtual Reality Sytem in Children With Acquired Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 30
Study Start Date: December 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358865

Locations
Israel
Tel Hashomer (THS) - Pediatric Rehabilitation Department
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00358865     History of Changes
Other Study ID Numbers: SHEBA-05-3847-AB-CTIL
Study First Received: July 31, 2006
Last Updated: April 30, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Virtual Reality
ABI
Projected system

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013