Wearable Technology in the Study of Raynaud’s Phenomena

Ascertainment of the Potential Impact of Wearable Technology on Raynaud’s

Phenomena Utilizing Data

Isobel Taylor

1,2,6

, Heitor Alvelos

2,6

, Susana Barreto

2,6

and Pedro L. Granja

1,3,4,5

Instituto de Investigação e Inovação em Saúde (i3S), Universidade do Porto, Porto, Portugal

Instituto de Investigação em Design, Media e Cultura (ID+), Universidade do Porto, Porto, Portugal

Instituto de Engenharia Biomédica (INEB), Universidade do Porto, Porto, Portugal

Instituto de Ciências Biomédicas Abel Salazar (ICBAS), Universidade do Porto, Porto, Portugal

Faculdade de Engenharia da Universidade do Porto (FEUP), Porto, Portugal

Faculdade de Belas Artes da Universidade do Porto (FBAUP), Porto, Portugal

up201501444@fba.up.pt, halvelos@fe.up.pt, susanaxbarreto@gmail.com, pgranja@i3s.up.pt

1 RESEARCH PROBLEM

Can wearable technology aid in the study of

Raynaud’s Phenomena?

Raynaud’s phenomena (RP) affects 3-20% of the

Population worldwide (Nhs, 2015). RP is the

vasoconstriction of the microvascular system in the

extremities, such as the digits, in response to cold

exposure or emotional stress. The prime quotidian

problems for sufferers are: ischemia to the

extremities, the pain this causes, loss of fine pincer

movements and the aesthetics (Fig 1.). The initial

symptom of an RP attack is often numbness; this is

not always noticed by the individual with RP.The

faster the attack is identified the sooner the

individual can attempt to re-establish blood flow,

therefore shortening the time the tissue has been

starved of nutrients. Current options include

Pharmaceutics which have side effects from

headaches to bleeding in the brain along with

problems in cross drug interactions. Pharmaceutics

also come at a cost, not just of the drug but also the

time spent with the Doctor which can be regular if a

drug that suits the individual is not easily found.

Whilst available wearables such as ski gloves and

heat focused garments limit function and dexterity

they also have a lack of data of the impact these

have. The presupposition is that a wearable data

collection device could create a database to aid in

the understanding of the condition itself as well as

any wearable or pharmaceuticals impact. The PhD

research continues from the researcher’s MRes in

Digital Media that questioned whether an RP attack

could be detected with a temperature sensor. The

study showed positive results which included taking

the skin surface and environmental temperatures of

predicting attacks initiating from data changes. The

Figure 1: Example of RP in fingers and toes. a. showing

the blue hue from the inadequate blood supply, ischemia,

the yellow/white pallor’s in b, c & d the initial loss of

blood flow from the vasoconstriction. (Wigley, 2015).

research will be advanced by focusing on data

gathering, for an accurate device, improving the

calculations involved. The aim is to create a device/

system to extract data from the skin concomitant

with external data including weather reports and geo

location incorporated through exploitation of a smart

phone for data gathering and assessment over time.

Interest also lies in how a designer can impact the

implementation of the research. The research will

centre on Primary Raynaud’s Phenomena, PRP, in

the fingers with the potential this could be used in

cases of Secondary Raynaud’s Phenomena, SRP,

and other effected extremities.

2 OUTLINE OF OBJECTIVES

 Ascertain if wearable technology can aid in the

study of symptoms of Raynaud’s Phenomena.

Taylor, I., Alvelos, H., Barreto, S. and Granja, P.

Wearable Technology in the Study of Raynaud’s Phenomena - Ascertainment of the Potential Impact of Wearable Technology on Raynaud’s Phenomena Utilizing Data.

In Doctoral Consortium (DCBIOSTEC 2017), pages 26-31

 Ascertain if predictions of attacks can be made

from routines, weather reports and geographical

data. Information with the potential to be

utilized by the individual through e.g. a smart

phone, as well as a database for quantitative

analysis.

 Create a model from the research for further

implementation in wearable technology, design

for health and wellbeing purposes.

 Report on the role of the designer as part of

development in medical/ wellbeing technology

within the field of wearable technology.

Focusing on wearable technology for health

teams, backgrounds and dates.

 Create a collection of information gained from

the PhD study on RP into a report.

3 STATE OF THE ART

This section describes:

3.1 Raynaud’s Phenomenon; the medical

condition,

3.2 Technology and wearables; the state of

technology & multidisciplinary wearable

technology developments

3.3 current market; products and research.

3.1 Raynaud’s Phenomenon

(RP) describes excessive vasoconstriction of the

digital microvasculature in response to cold

exposure and emotional stress (Pauling, 2013). This

causes vessels in the extremities to constrict,

stopping blood flow, short term this can be painful,

longer term damaging, long term can cause

irreversible damage. Raynaud’s comes in 2 forms,

Primary, PRP, and secondary, SRP. Primary

Raynaud’s is idiopathic, a condition in itself,

secondary RP is a symptom of another condition.

Amputations are not common but do occur in RP

patients; amputations occurring from vascular

diseases, which includes RP, counts for the highest

number of amputations in the developed world

(Ziegler-Graham, 2008). Current solutions for

patients leave a lot to be desired; medical

prescriptions have substantial side effects, effects

from headaches to bleeding in the brain. Along with

the main non-pharmaceutical suggestion is ‘avoid

the cold’ (Raynauds, 2009). The research predicts

gathering detailed quotidian data will aid in research

and further illuminating the details of RP by taking

recordings including temperature readings; usually

only taken in clinical environments whereas RP

attacks take place at home, at work, when traveling.

The utilization of individual and local data will have

great potential in the improvement of the wellbeing

of those with the condition on a quotidian basis. For

the purpose of the PhD research I will be focusing

on the hands and ensuring the outcome can be

adapted for the other effected extremities; toes, nose,

ears. Medically the focus will be on Primary

Raynaud’s though in many cases the outcome is

likely to inherently be of use to those with

Secondary Raynaud’s. From observations at the

2015 Raynaud’s and Scleroderma conference UK it

became evident that the patients were not satisfied

with the current methods of coping with the ailment.

A search of current medications and devices

revealed problems, listed in the research problem,

highlighted by patients interviewed before and

during the conference. [The 2016 Raynaud’s

conference was much the same in regard of the

patients finding the current options lacking].

3.2 Technology and Wearables

There has been a growing increase in the space for

designers to collaborate in science, health and

technology, particularly noticeable in wearable

technology teams. Wearable technology has and is

able to bring together designers, scientists and

engineers to incorporate the technology into a form

fitting for the identified user and purpose. This has

been a rare occurrence in history from Leonardo da

Vinci [1452 - 1519]; design, art, medicine, science

and engineering, James L. Acord [1944 - 2011]; art,

nuclear science, Eduardo Kac [1962-]; art, biology.

An example of a current wearable technology team

is Studio XO with founders Benjamin Males,

engineer, and Nancy Tilbury fashion design, (Studio,

2016). Wearable technology as a field has hit mass

media with its own reality TV show, founded by

Intel: ‘America’s greatest makers’

(Americasgreatestmakers, 2016). Although a

relatively young field, in regard to fields such as

biology and chemistry, this in part goes to show the

increase in interest and popularity. The most

common focus for wearable technology regarding

wellbeing is in sports, fitness and elderly care, “As

of September 30, there were 266 wearable devices

on the market (including 118 fitness wearables)”

(Herz, 2014). This is not to say wearable technology

is the universal answer to healthcare problems;

“Potentially, these devices could give patients direct

access to personal analytics that can contribute to

their health, facilitate preventive care, and aid in the

Wearable Technology in the Study of Raynaud’s Phenomena - Ascertainment of the Potential Impact of Wearable Technology on Raynaud’s

Phenomena Utilizing Data

management of ongoing illness. However, how this

new wearable technology might best serve medicine

remains unclear. “(Piwek, 2016) Wearable

technology is on the rise, yet not all who purchase/

obtain devices will keep up use and devices may not

work with accuracy; “This systematic review

indicated higher validity of steps, few studies on

distance and physical activity, and lower validity for

energy expenditure and sleep. The evidence

reviewed indicated high interdevice reliability for

steps, distance, energy expenditure, and sleep for

certain Fitbit models. As new activity trackers and

features are introduced to the market,

documentation of the measurement properties can

guide their use in research settings. “(Evenson,

2015). Reliability of the technology is of great

importance, particularly with a medical condition

focused device.

3.3 Current Market and Research

The financial market of wearable technology in

health is on the rise. According to a report by Pira

International (now called Smithers Pira, 2012) by

2021 the smart material market will be worth just

under €2,000 million, medical and healthcare

making up just under 1/3

of the market (Wilson,

2011).

Specifically regarding RP; most heated gloves

and socks on the market have been ski or fishing

based with a smaller number for hiking and motor

bikers. RP sufferers at the SRUK conferences cite

use of hand warmers and normal thick gloves and

socks but none have cited use of any RP specific

made product apart from silver gloves. Silver gloves

and socks whilst marketed as an aid to RP have very

little scientific evidence to prove this. RP also has a

particularly high rate of the placebo effect. However,

although RP sufferers have cited use of silver

products none have given any particular feedback on

their use other than a thin glove being useful at times

and the ability to use touch screens, both of which

could be achieved with a non-silver glove. This is

not to say silver is not useful: evidence does show

antibacterial properties and conductivity that will be

assessed as part of the material options in practical

developments (see methodology). Also, these

devices do not collect data or make predictions.

Current devices in research specifically for RP

include 2 groups from Universities Nottingham

Trent and Virginia Commonwealth. Nottingham

Trent have funding from the Raynaud’s and

Scleroderma society UK (Sruk 2016) for developing

a heating glove, previously they have developed a

thread for monitoring temperature within socks to

test for ulcers in patients with diabetes. At the

Virginia Commonwealth university an engineering

student developed a 2-layer glove to heat fingers and

hands in regard to RP (Ugincius, 2016). If the

Virginia group collect and use data, as the mediation

seems to suggest, the interest to this research project

will lie in what data they collect and how they use it.

Clinical analysis of RP is conducted in controlled

environments and with patient information (Murray,

2015). Wearable technology allows data to be

collected over prolonged periods of time at the

patient’s home. This data collected and processed

could show patterns such as times of day RP attacks

are most common, temperatures that trigger RP

attacks, sudden loss of blood flow. Within clinical

environments tests to study RP include the cold

challenge which examines temperature of the fingers

following exposure to 15°C water submersion for 60

or 120 seconds over 25 minutes using a thermal

imaging camera. Within the challenge the specialist

looks for the rate the finger temperature changes

over 25 minutes. The research will broaden this

temperature reading study to days, weeks, months

and more. Including the ability to record attacks that

may be related to weather conditions as well as

temperature levels in the locations that matter most

to the patients as managing their condition in the

locations the attacks occur.

4 METHODOLOGY

The presupposition is that the answer will be found

in the field of wearable technology; this field

enables real time data capture and analysis

concomitant with an external direct impact on the

affected area/s. Real time data includes human and

external such as finger temperature, weather reports

and geo location. The aim is to achieve this through

qualitative practice-based research by use of the

appropriate materials, currently being identified, in

articulation with syntax capable of learning and

adapting and with the capability of prediction to

alert the user. Research initiates with a foundation of

literature and market research focusing on the users;

interviews and surveys with doctors, specialists,

patients and relevant agents.

The overall methodology being followed is

represented by the following action research cycle:

DCBIOSTEC 2017 - Doctoral Consortium on Biomedical Engineering Systems and Technologies

Figure 2: Methodology diagram, based on the general

action research cycle diagram.

(Fig. 2) When iii. is the evaluations of i. and ii. then iiii. is

the specific testing of prototypes and finalisation of the

research.

The research focuses on collecting data for the

individual user and for an overall study towards RP

research.

The method will test usability and performance

of a wearable device for collecting data and software

for mobile phones for gathering and communication.

To be completed through finding, developing and if

need be synthesizing optimum materials and parts

for detecting and code for mobile software.This

research will be principally compiled with primary

and secondary research utilizing key academics,

medical doctors and researchers, in addition to

secondary research based on extensive archived

material, internet sources, published papers, patents,

market reports, company websites, conference

reports, magazines, newspapers and newsletters.

A series of user aims/criteria are being compiled

including; How safe is it? And Durability? forming a

flow chart to analyse the developments and final

device.

Resources; material laboratories and time,

executing this research in Porto means access to

material science academics and laboratories for

developing the physical device. Within the

researchers MRes physical parts and materials were

obtained through samples issued by companies on

request and meeting any additional costs,

expectation is that this method of compiling parts for

research will carry forward.

The action research cycle will be addressed in 3

segments;

4.1 Foundation,

4.2 Core,

4.3 Finalisation.

4.1 Foundation

The foundation is formed from comprehensive

understanding of the condition itself and the

problems that restrict daily function. The outcome of

this segment will be a list of criteria enabling the

assessment of a device for RP, in order to ensure that

the designed and developed outcome meets the

needs it is intended for and to comprehensively

answer the research question. To form this criteria,

the methods being used are as follows: Interviews

and surveys with RP patients, Information from

medical specialists, observations made from the

researcher in reviewing the information and

literature review. These will include interviews and

observations of persons without RP as a person with

RP may not know or remember the difficulties in

certain situations even without RP. These potential

findings are not to be ignored as if there is an aid to

the problem it will still be of use to the RP sufferer

but it is important to distinguish what it helping in

regards to RP and what is helping RP aside. This

section includes the literature and market review.

Within the literature the topic spans many

disciplines including: medicine, data processing,

product design, engineering and technology.

Although most of this is being accomplished within

the early stages of the PhD research, this work will

remain ongoing throughout as the information may

be updated and crucial elements may be found at any

time throughout the research time frame. A list of

criteria the device should meet will be formed from

section 4.1; the list is to be updated as and when new

information is obtained for the outcome to be

assessed against.

4.2 Core

The core of the PhD will lie in the prototyping, data

collecting, analysis and developments. Although

focus lies on the data and algorithms the device will

use to inform the user and aim to predict attacks.

However, materials and technology used are also

highly important. Materials used must allow the

outcome device to be comfortable to wear,

functional, durable, aesthetic and in many ways

above all desirable. A device that is highly

functional for its use but not desirable will not be

used sufficiently and will ultimately fail at its

purpose. The desirability will be evaluated

throughout the process from materials, designs,

shape, comfort, static, sound and feel against other

materials, not just skin. The device prototypes will

use temperature sensors with Bluetooth to transmit

Wearable Technology in the Study of Raynaud’s Phenomena - Ascertainment of the Potential Impact of Wearable Technology on Raynaud’s

Phenomena Utilizing Data

to a mobile app. The mobile app will also be

developed in this segment to tie the wearable

sensors, weather data and communication to the user

together for assessment.

The outcome of this segment will be: The

identification of risk factors employable in wearable

technology and how to record the risk factors,

physical prototypes, a mobile app to assess the

location of the user utilising online weather data and

routines found through correlations of temperature

drops over the course of a day.

4.3 Finalisation

This section concerns trials, testing and evaluation.

Prototypes are to be tested against the developed

criteria. Prototypes to be tested on RP patients to

gain feedback and alterations to be made for further

developments. Accuracy of the data the prototypes

record to be assessed and tested. Also mass scale

development to be assessed, questioning how the

prototype could be developed in a factory setting.

This also entails a costing evaluation to compare

current methods in managing the condition against

the potential of the prototype to aid in understanding

of when the attacks are problematic to aid the user in

adaption in their daily routines. Software will also be

written to collect data from individuals to create a

large database for finding patterns in RP attacks and

environmental changes that effect RP.

5 EXPECTED OUTCOME

 A report on whether wearable technology, in

the form of the prototypes developed, can aid in

research and prediction of symptoms of

Raynaud’s Phenomena.

 Various prototypes using human biological data

to understand when an attack takes place,

showing designs tested and evaluated.

 An app for prediction and prevention with the

ability to work with the wearable technology

prototypes.

 A study ascertaining the potential difference a

wearable device, with and without use of the

developed app, can make to someone with a

medical/wellbeing condition. Highlighting the

gain of control over the personal data and

environment.

 A database of temperature findings, both from

literature reviews and case studies. / Database of

finger temperatures, ‘normal’ exposed to

particular environments and recovery

 A model from the research for further

implementation in wearable technology, design

for health and wellbeing purposes.

 A report on the role of the designer as part of

development in medical technology within the

field of wearable technology. Focusing on

teams working on wearable technology for

health, their backgrounds and dates.

 A model from the research for further

implementation in wearable technology, design

for health and wellbeing purposes.

6 STAGE OF THE RESEARCH

At the current stage of the research criteria is being

extracted from the foundation research for the

prototype assessment. This includes literature review

of RP from the medical field, recent wearable

technology devices aimed at RP patients and data on

continued use of wearable technology for generating

personal data regarding health, wellbeing and

fitness. The core of the research is under way in

testing what materials will be most favourable to

establish the form of the wearable and tie in with the

sensors needed. Algorithms are being drafted to

analyse the data from the wearable and weather data

to process into easily readable charts. As part of the

ongoing foundation review on the RP condition

conferences are being attended including the SRUK

annual patient conference bringing together RP

experts, doctors and patients. Surveys are being

developed to gain a more personal understanding of

how RP effects sufferers during their daily lives.

These will be sent out to the SRUK members, the

Scleroderma and Raynaud’s association UK. RP

patient’s groups within Porto will also be sought to

compare results between different geographic

locations.

ACKNOWLEDGEMENTS

Isobel Taylor is grateful to The Portuguese

Foundation for Science and Technology (FCT) and

the Doctoral Program in Design of the University of

Porto for her PhD scholarship ref.

PD/BD/128020/2016.

DCBIOSTEC 2017 - Doctoral Consortium on Biomedical Engineering Systems and Technologies

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Wearable Technology in the Study of Raynaud’s Phenomena - Ascertainment of the Potential Impact of Wearable Technology on Raynaud’s

Phenomena Utilizing Data