NCT04179916

Brief Summary

The purpose of virtual medicine is to minimize direct contact and impact on human body during treatment. Taking into consideration the increasing accessibility of high quality electronic devices, their immense computing powers, and the continuously developing Internet infrastructure, the advancement in this area is only a matter of time. The project aims to analyze physiological reactions to stimuli in virtual reality in order to select appropriate stimulations for a group of pulmonary and cardiac patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

November 19, 2019

Last Update Submit

June 19, 2020

Conditions

Keywords

virtual realityVRHRVthermal imaging

Outcome Measures

Primary Outcomes (1)

  • Thermal Imaging

    The thermographic camera Flir 435-0006-03 will be used for measurements. The forearm and hand area will be observed. Photographs will be taken with a sequence of 30 seconds.

    30 minutes

Secondary Outcomes (1)

  • Heart Rate Variability

    30 minutes

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Participants between 21 and 25 years, the Faculty of Physical Education and Physiotherapy of the Opole University of Technology Students

Diagnostic Test: stimulation in virtual reality

Interventions

HTC VIVE pro was used to stimulate patients in virtual reality. The glasses enable high resolution and high fluidity (90Hz) images to be displayed. The display used inside the glasses, OLED class, allows for accurate color replication. Numerous sensors placed in the glasses (such as gyroscope, accelerometer, magnetometer) supported by dedicated processors processing data from the sensors, instantly transfer the movement of the head of the rehabilitated person to virtual reality. Such a set allows to achieve full immersion in the virtual world. Various scenarios will be presented during the stimulation, such as beach, snow landscape, darkened room, rollercoaster ride. It was planned to submit 3 scenarios with a total stimulation time of up to 20 minutes.

Healthy volunteers

Eligibility Criteria

Age21 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age: 21-25

You may not qualify if:

  • diagnosed internal diseases
  • diseases and injuries of the locomotor system impairing the function of transport, especially injuries of the upper limb
  • claustrophobia
  • eye disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Camillo IRCCS

Venice, 30126, Italy

Location

The Ministry of the Interior and Administration Hospital

Głuchołazy, 48-340, Poland

Location

Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology

Opole, 45-758, Poland

Location

Study Officials

  • Sebastian Rutkowski, PhD

    The Opole University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: For this study it was assumed to expose healthy volunteers for stimuli in the immersive virtual reality
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 27, 2019

Study Start

December 10, 2019

Primary Completion

January 13, 2020

Study Completion

January 17, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

It was decided to provide free access to the analysed data. The data will be available upon request sent to PI: s.rutkowski@po.opole.pl.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months

Locations