GNEUROPATHY: Validation Process at Clinical Environment

Claudia Quaresma

1,2,3

, Madalena Gomes

, Heitor Cardoso

, Nuno Ferreira

, Ricardo Vigário

1,2

Carla Quintão

1,2

and Micaela Fonseca

1,2,3,4

Departamento de Física, Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa,

2892-516 Monte da Caparica, Portugal

Laboratório de Instrumentação, Engenharia Biomédica e Física da Radiação (LIBPhys-UNL), Departamento de Física,

Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa, 2892-516 Monte da Caparica, Portugal

VR4NeuroPain, Rua Comandante António Feio nº26 1C1, 2800-255 Almada, Portugal

Universidade Europeia, Laureate International Universities, Estrada da Correia, nº53, 1500-210 Lisboa, Portugal

{heitor.cardoso, nuno.ferreira}@vr4neuropain.com

Keywords: Rehabilitation, Spinal Cord Injury, Evaluation, Device.

Abstract: Spinal cord injuries are one of the most traumatic situations with a major impact on a person's quality of

life. This type of injury have a extremely impact in the performance of daily life activities not only due to

motor alterations but also due to the appearance of neuropathic pain Throughout the rehabilitation process

the evaluation and intervention methodologies are not very systematic and are not personalized. Thus, to

bridge this gap, the VR4NeuroPain was developed a technology that associates virtual reality with a glove

"GNeuroPathy". The glove "GNeuroPathy" allows the collection of physiological parameters, namely to

identify the electrodermic activity (EDA) while the patient carries out activities in an immersive

environment. The main objective of this article is to present the validation process of the "GNeuroPathy" in

clinical context. "GNeuroPathy" was applied to a group of 17 individuals with incomplete spinal cord

injury. The results showed that "GNeuroPathy" is easy to apply and is suitable for comfort and texture. Data

were also collected from EDA and it was found that there is a significant difference in signal amplitude in

patients with low and high functionality.

1 INTRODUCTION

Spinal cord injury (SCI) is one of the most

devastating neurological injuries, as the spinal cord

is the main communication route between the brain

and the rest of the body, so injuries at this level are

devastating to the patient, both physically and

psychologically. SCI can occur following trauma to

spinal cord and also because of a variety of

pathologies (e.g. congenital, transverse myelitis,

spinal meningitis) SCI leads to dramatic losses in

neurons and synaptic connections, and consequently

function. Worldwide, the incidence of SCI ranges

from 3.6 to 195 per million (Massetti and Stein,

2018) leading to a major medical problem because

currently there is no way to repair the central

nervous system and restore function.

The long-term disability from SCI results not

only from the initial loss of function but also from

the complications that accumulate (such as severe

spasticity, infections, osteoporosis and pathologic

bone fractures) (Jazayeri et al., 2015; McDonald and

Sadowsky, 2002). A major long-term complication

is muscle wasting, where rehabilitation plays a

crucial role in the restoration and/or maintenance of

motor skills. These disabilities affect patients’ ability

to accomplish real-life activities of daily living

(ADLs), and often involve critical sub movements,

including reaching and/or grasping (Nathan et al.,

2009).

Despite the loss of functionality is considered a

major long-term complication, the neuropathic pain

can be determinant for the patient’s inability to

return to ADLs, production and entertainment.

Accordingly, it is imperative and crucial to

develop new technologies that have a significant

impact on the rehabilitation process of the SCI.

Virtual reality has become increasingly popular and

available being integrated into intervention

programs, such as for pain and stress reduction,

Quaresma, C., Gomes, M., Cardoso, H., Ferreira, N., Vigário, R., Quintão, C. and Fonseca, M.

GNEUROPATHY: Validation Process at Clinical Environment.

DOI: 10.5220/0007579702750279

In Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019), pages 275-279

ISBN: 978-989-758-353-7

275

skills training and rehabilitation (Chen et al., 2009).

Therefore, an innovative solution was created

called "VR4NeuroPain", which associates virtual

reality with sensory and motor stimulation

(Quaresma et al., 2018). The system consists of two

components: virtual scenarios and a glove -

"GNeuroPathy" - monitors electrophysiological data

in real time.

With the aim of providing patients with an

innovative environment for the rehabilitation

process. The "VR4NeuroPain" system allows

patients to have contact with an immersive

environment that aims to (Quaresma, et al., 2018):

● motivate for the rehabilitation process;

● play an active role in the rehabilitation process;

● promote quality of life and well-being;

● control the achievement of fine and global

movement;

● distinguish tactile sensory stimuli;

● stimulate technological literacy.

For that reason, the use of interactive technologies in

a rehabilitation process allows to reduce the time

spent in that process and greater economic

sustainability of the units of the health sector. In

order to guarantee the applicability of the system it

is necessary to carry out the validation of all the

components. Thus, "GNeuroPathy" has already been

applied in people with no associated pathology and

it has been found to be easy to apply and meets the

proposed objectives.

The present work has as main objective to

present the validation process of the glove

"GNeuroPathy" in clinical context.

2 MATERIALS AND METHODS

The study was approved by the Portuguese Ethics

Committee of the Medicine and Rehabilitation

Center of Alcoitão, in Portugal. Each participating

subject was informed about the procedures and the

objectives of the study, prior data collection, and

signed a consent form with this information.

All data was collected, during 1 month, from a

cohort of patients with spinal cord injury attending

the occupational therapy department, at the

Medicine and Rehabilitation Center of Alcoitão. The

inclusion criteria for the present study were that each

patient had incomplete spinal cord injury.

The process of validating "GNeuroPathy", in

clinical context, is divided in three parts:

1. Usability – examines the subject's degree of

satisfaction, when using the glove;

2. Data collection procedure – assesses the

performance of the protocol;

3. Data analysis – prototyping of the analysis

procedure, and the interpretation of its outcomes.

Glove “GNeuroPathy” System.

The "GNeuroPathy" glove (Figure 1) is easy to put

on, allows object manipulations and currently

integrates two types of sensors that collect electro-

dermal activity (EDA) and muscle activity (EMG)

data. To record the EMG and EDA signals, a

Bitalino acquisition module; a pair of EMG sensors

and another pair of EDA sensors were used. To

connect the sensors to the subject, 2 Ag / AgCL with

adhesive electrodes stabilized with solid adhesive

were used for each sensor (TIGA-MED Gold 01-

7500, TIGA-MED GMBH, Germany) (Guerreiro et

al., 2013; Guerreiro et al., 2014).

Figure 1: The glove "GNeuroPathy".

Bitalino, together with the sensors and the

electrodes used are shown in Figure 2. The recording

device collects the biological signals simultaneously,

with a 16-bit resolution and sampling frequencies of

up to 1000 Hz. All data is transmitted, via Bluetooth,

from Bitalino to the computer for processing. In the

latter, the software used was Plux’s proprietary

OpenSignals (Guerreiro et al., 2013; Guerreiro et al.,

2014).

Figure 2: The components of the Bitalino and the EDA

sensors (Guerreiro et al., 2013; Guerreiro et al., 2014).

Glove “GNeuroPathy” Data Collection.

After installing the glove, with all sensors securely

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attached to the skin, and the hand held by the

therapist, stimulation was applied to the hand, at the

level of the fingers, in a pre-determined sequence.

The first stimulus consisted of a touch, with a pin, to

the hand. Subsequent stimuli consisted of sandpaper,

cotton, hot and cold contacts with the skin. To

reduce the psychological effects of stimulus

preparation, the subject was asked to look in the

opposite direction to the stimulated hand

The data collection procedure is shown in Figure

Each stimulus was applied for 10 seconds.

During the application of each stimulus, EDA

parameters were collected. Although both EDA and

EMG could have been recorded, in connection with

the use of the “GNeuroPathy” glove, this

preliminary, validation work collected only EDA

information from all subjects. Three collections were

made for each stimulus type. The goal was to assess

the robustness of the data collected, as well as

possible habituation effects, associated with the

repeated application of each stimulus type.

Figure 3: The figure shows the data collection protocol.

Characterization of the Sample.

The sample consisted of 17 patients (7 women and

10 men), aged between 22 and 81 years, with an

average age of 55 +/-18 years and an average body

mass index of 26 +/- 4. Seven patients did not report

having pain; and the remaining ten scored, in the

visual analogue scale (Boonstra et al., 2008), as

shown in Figure 4.

Figure 4: Reported pain for the subjects participating in

the study, following the visual analogue scale (Boonstra et

al., 2008).

Validation of Data Collection Procedure.

The following data collection protocol was applied

to all patients:

1. Describe the study’s objectives and obtain the

informed consent;

2. Collect demographic data from the participants;

3. Placement of the electrodes on the anterior face

of the right hand. A grounding electrode is also

placed in the styloid process of the ulna;

4. Placing the glove;

5. Data collection, following the protocol described

in Figure 3;

6. Removal of the electrodes and glove

7. Fill patient’s satisfaction questionnaire,

regarding the use of the glove.

3 RESULTS

Usability Tests.

These tests were conducted to evaluate the

parameters of Visual aspect; Accessibility in place;

Comfort; Fixation and Texture, in a scale where

each of them was considered as Unsuitable, Partially

adequate or Suitable.

During the usability tests it was found that 94%

of all participating subjects considered

"GNeuroPathy" to be "adequate", from visual

appearance and comfort perspectives. In addition,

65% of all patients recommended the use of

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277

Different type of stimuli

"GNeuroPathy", and 82% reported that its fixation is

"adequate". None of the patients considered the

device “Unsuitable”.

Figure 5: Patients' degree of satisfaction.

Clinical Observations.

After validating the usability of the GNeuroPathy

device, physiological data was collected with it. The

duration of one full study, running over all stimuli

within the protocol, lasted not more than 10 minutes.

The recorded EDA consisted of averages of the

electrodermal activity, within a fixed temporal

window length, after the application of the

respective stimulus (Figure 6).

Figure 6: Values of averaged EDA, for all stimuli types,

and three different groups of patients suffering from

incomplete spinal cord injury. For comparison, also the

values found from subjects reporting no level of

pathological pain.

We observed that, throughout all patients, the

EDA means changed rather highly. From the 17

subjects, about 5 of those presented very low values,

when compared to a similar study performed on

healthy subjects (Quaresma et al., 2018)). In

addition, 5 had close to “normal” EDA values. The

remaining 7 had values spreading from one end to

the other. Hence, we divided our subjects according

to those characteristics, as summarized in Figure 6.

Two significant considerations may be drawn

from the results reported. In an immediate look, it is

clear that any type of stimulation seems to result in

an increase in EDA response higher than the basal

response, ie., a condition where no stimulation

occurred. In addition, the “hot” stimulus produced

the highest response, whereas all others seem rather

similar to one another.

The second, and possibly the most important

result, is that the five patients with the most severe

functional limitations, represented in the graph with

a blue color, displayed the lowest EDA values. Even

the group with mild limitations, in red, have values

that are considerably lower than the ones displayed

by the healthy group. Finally, patients with rather

good functionality differed little from the group of

healthy subjects – both in EDA values themselves,

as well as in the relative magnitude variation with

the type of stimulus employed.

4 CONCLUSIONS

The principal objective of this article is to present de

validation process in a clinical context.

For this

purpose, the glove "GNeuroPathy" was utilized in a

study comprising 17 patients with incomplete spinal

cord injury, to collect EDA data. In addition, a

usability test was also performed.

This research is part of an ongoing project for

system development, called "VR4NeuroPain". In

this article, the tests performed on the glove

prototype "GNeuroPathy", the physical element of

the "VR4NeuroPain" system, were presented.

This study contributed to obtaining a clear

feedback on the design and usability of the

prototype. The data collection procedure, in the

context of EDA response to external stimulation of

the hand was also tested.

Although outside of the main purposes of this

work, we have observed that EDA is a good

indicator of the level of functionality in patients with

incomplete spinal cord injuries. As such, one may

foresee that a device such as “GNeuroPathy” may be

employed to help diagnosing said disease, as well as

assess the benefits of given rehabilitation

interventions.

In the future we will also develop a software

platform where to add all algorithms required for

physiological signal processing. In addition, the

glove – "GNeuroPathy" – must also be validated

associated with the other parts of the system. Tests

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in individuals with neuropathic pain will be

performed within the "VR4NeuroPain" system, and

compared with the conventional procedures, in order

to prove the reliability of the system.

The system can be used by multiple users, such

us physicians and occupational therapists, and will

allow us to apply innovative and interactive

methodologies of intervention, promoting the

process of rehabilitation.

ACKNOWLEDGEMENTS

The authors would like to thank all the healthcare

professionals of Medicine and Rehabilitation Center of

Alcoitão The authors would like to thank Collide for the

help and support provided in this investigation.

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