NCT00358865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 7, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

July 31, 2006

Last Update Submit

April 30, 2008

Conditions

Keywords

Virtual RealityABIProjected system

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • 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)

You may not qualify if:

  • Significant visual limitations
  • Premorbid, progressive mental disorder or neurological injury
  • Premorbid learning disability
  • healthy subjects
  • developmental disorders
  • significant medical problems
  • neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Hashomer (THS) - Pediatric Rehabilitation Department

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • amichay brezner, PhD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR
  • Tamar Weiss, prof.

    Haifa university, OT Department

    STUDY DIRECTOR
  • Brat Orit, PhD

    Tel Aviv University, OT Department

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Study Start

December 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

May 7, 2008

Record last verified: 2008-04

Locations