Evaluation of Physiological Reactions in Virtual Reality

Virtual Reality Clinical Trial

Official title:

Evaluation of the Physical Reaction in Immersive Virtual Reality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179916
• Other study ID #: OpoleUofTech
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: June 2020
• Source: The Opole University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In recent years, the literature has shown the results of many studies undertaking the possibility of applying new technologies in rehabilitation as elements of optimization, including Virtual Reality (VR). VR can be based on computer programs that use a three-dimensional camera or sensors placed on the body to read the patient's movements and transfer them to the screen in a computer-created environment. For the most part, VR research has focused on analyzing the therapeutic potential of typical virtual games, which are not designed for clinical use, but for entertainment and relaxation.

Rehabilitation in virtual reality has also become one of the common challenges for physiotherapists and IT specialists, who develop improvement programs dedicated to various diseases and illnesses. Numerous publications are available in the scientific literature, describing the possibilities of using VR as a diagnostic and therapeutic tool. The possibility of diagnostic application of the technology in motion analysis has been demonstrated. The use of VR in the analysis of respiratory mechanics and training of pulmonary patients has also been noted. Most of the available studies concern the rehabilitation of neurological patients. There are many studies available, including meta-analyses, which confirm that the best results of rehabilitation can be achieved through the use of traditional neurological rehabilitation combined with rehabilitation conducted in virtual reality. Only few papers describe physiological reactions, including heart rate variability (HRV) and thermovision diagnostics during stimulation in immersive virtual reality.

The aim of the study is to evaluate the physiological reactions of the organism in healthy subjects during stimulation in immersive virtual reality.

This study is focused on:

Monitoring physiological parameters including heart rate variability (HRV) and thermal imaging (TI) change in healthy subjects during stimulation in immersive virtual reality.

The result of proposed research may be the answer to the following questions:

1. What changes in heart rate variability occur during the stimulation of various types of stimuli in virtual reality?

2. Which alterations in body temperature, especially in the distal parts of the upper limb, occur during stimulation in virtual reality?

The evaluation session will be conduced in the following scheme in static seated position:

1. Preparation of the research equipment

2. Measurement without stimulation in virtual reality: HRV, TI - 6 minute

3. Measurement in virtual reality: HRV, TI - simulation of cold environment (snow, wind) - 6 minute

4. Measurement in virtual reality: HRV, TI - simulation of warm environment (the beach, the sea) - 6 minute

5. Measurement in virtual reality: HRV, TI - simulation of terrifying environment (a dark room, ghosts) - 6 minute

6. Measurement without stimulation in virulent reality: HRV, TI - 6 minute

7. Completion of the measurements

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 17, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Age: 21-25

Exclusion Criteria:

1. diagnosed internal diseases

2. diseases and injuries of the locomotor system impairing the function of transport, especially injuries of the upper limb

3. claustrophobia

4. eye disorders

Related Conditions & MeSH terms

• Virtual Reality

Intervention

Diagnostic Test:
• stimulation in virtual reality
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.

Locations

Country	Name	City	State
Italy	San Camillo IRCCS	Venice
Poland	The Ministry of the Interior and Administration Hospital	Glucholazy
Poland	Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology	Opole

Sponsors (2)

Lead Sponsor	Collaborator
The Opole University of Technology	IRCCS San Camillo, Venezia, Italy

Countries where clinical trial is conducted

Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart Rate Variability	Throughout the examination, heart rate will be monitored by the Polar H10 optical heart rate sensor. Polar H10 is a monitor armband that combines versatility, comfort and simplicity.	30 minutes