NCT00591448

Brief Summary

The purpose of this study is to evaluate the use of Virtual Reality (VR) technology during Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Research questions: Do patients have increased joint Range of Motion (ROM) and reduced pain when using VR during PT compared to PT/OT when VR is not used? Do scores on an imaging ability scale correlate with the effects of VR when used with PT/OT? Do adults and children differ in their ability to engage in the virtual world?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

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

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

December 26, 2007

Last Update Submit

October 16, 2012

Conditions

Burn

Keywords

Thermal injury

Outcome Measures

Primary Outcomes (1)

  • Improved pain scores

    18 months

Secondary Outcomes (1)

  • There are no secondary outcomes

    18 months

Study Arms (1)

Virtual Reality

EXPERIMENTAL

Patients with burns participate in VR during occupational therapy (OT) or physical therapy (PT) sessions ranging from 2 to 9 min in length

Other: Virtual Reality (VR)

Interventions

Virtual Reality (VR)OTHER

See above

Virtual Reality

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Able to complete subjective evaluations of pain
  • English-speaking
  • Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
  • Able to communicate orally
  • Pain associated with PT/OT
  • Age six years and above

You may not qualify if:

  • Incapable of indicating subjective evaluation of pain
  • Non-English-speaking
  • Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet.
  • Demonstrating delirium, psychosis, or Organic Brain Disorder
  • Unable to communicate verbally
  • Significant developmental disability
  • Extreme susceptibility to motion sickness
  • Reports having no pain/full range of motion during physical therapy
  • Seizure disorder
  • Frostbite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Lee Faucher, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

October 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 17, 2012

Record last verified: 2012-10

Locations

US(1)