Optimization Process of an Innovative Rehabilitation Device

based on Pre-Clinical Results

R. BERNARDES1, V. PAROLA1, R. CARDOSO1, H. NEVES1, A. CRUZ1, W. XAVIER2,

R. DURÃES3, C. MALÇA4,5

1Health Sciences Research Unit: Nursing (UICISA: E),

Nursing School of Coimbra,

Av. Bissaya Barreto 143, 3000, Coimbra,

PORTUGAL

2WISEWARE Lda.,

Rua 12, Zona Industrial da Mota, 3830-527 Ílhavo,

PORTUGAL

3ORTHOS XXI, Unipessoal Lda.,

Rua Santa Leocádia 2735, 4809-012 Guimarães,

PORTUGAL

4 Department of Mechanical Engineering,

Polytechnic Institute of Coimbra-ISEC,

Rua Pedro Nunes, 3030 Coimbra,

PORTUGAL

5Centre for Rapid and Sustainable Product Development,

Polytechnic Institute of Leiria-CDRSP,

Rua de Portugal, 2430 Marinha Grande,

PORTUGAL

Abstract: Commercially available technical solutions used in physical rehabilitation processes have not

responded effectively to the crucial needs of customized rehabilitation programs. As such, a partnership

between a nursing school, technological enterprises – ORTHOS XXI and WISEWARE - and engineering

institutes was established to implement a project entitled ABLEFIT to overcome the identified lack of technical

solutions in the market. ABLEFIT has the main purpose of making available a rehabilitation device in the

market that ensures the implementation of physical rehabilitation programs in a controlled and interactive way

so that patients can regain their physical, psychological, and social functions as soon as possible. The loss of

these capabilities is closely related to Prolonged Immobility Syndrome (PIS), being the morbidity and mortality

associated with the complications resulting from prolonged inactivity or even a sedentary lifestyle seen both in

the elderly population and in adults and young people with some type of restriction of mobility or disability.

This paper describes the optimization process of the ABLEFIT device based on the pre-clinical trials

performed. The optimization process starts with the design of an initial prototype, followed by the construction

of a second prototype, and finally the planning of an additional iteration, which will involve the construction of

a third prototype that will look identical to the version that will be available in the market. The two iterations of

the ABLEFIT prototype device developed up to now provide undeniably an advanced solution to support

physical rehabilitation, since they combine a biomechanical system to aid physical exercise, in passive and

active modes, in bed and a wheelchair, with a control system for monitoring and storing biofeedback variables

and motivational stimulus through interaction with gamification. The ABLEFIT device significantly contributes

to the reduction of morbidity and mortality associated with complications resulting from prolonged inactivity.

Key-Words: - Immobility Syndrome, Rehabilitation Devices, Rehabilitation Customized Plan, Active/Passive

Customized Training Plans, IoT, Gamification, Pre-Clinical Trials

Received: May 25, 2022. Revised: February 20, 2023. Accepted: March 28, 2023. Published: April 28, 2023.

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DOI: 10.37394/23209.2023.20.17

R. Bernardes, V. Parola, R. Cardoso,

H. Neves, A. Cruz, W. Xavier,

R. Durães, C. Malça

E-ISSN: 2224-3402

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1 Introduction

Regardless of the cause that gave rise to it, e.g.

pathology, trauma, aging, injury, etc., Prolonged

Immobility Syndrome (PIS) has serious

consequences on the functioning of the human body,

whether due to loss of muscle mass or increased

stiffness of the joints, [1], [2], [3], [4], [5]. The

negative impact of this phenomenon assumes

several dimensions, both in terms of the individual's

health and the inherent social and economic effects,

[6], [7], [8], [9], [10]. As such, it is urgent to

develop and implement strategies and technical

solutions that minimize the consequences of PIS,

thus helping patients to regain their physical,

psychological, and social functions as soon as

possible.

Nevertheless, the solutions available in the

market are very limited and limiting, [7], [8], [9],

[10], [11], [12], [13], [14], [15], [16]. An integrated

solution that ensures: i) the application of

rehabilitation programs adapted to each user profile,

ii) the application to beds and wheelchairs, iii) the

execution of exercises in both active and passive

modes, iv) the execution of exercises of both the

upper and lower limbs, v) the execution of linear

and curved trajectories and rotational movements,

vi) the monitoring of patient's vital signs over time,

and vii) data recording and storage, is not available

in the market. Additionally, devices available in the

market have no IoT communication system or other

types of human-machine interface, which is

essential not only for controlling, recording, and

storing the parameters defined in the rehabilitation

plan but also for playing a key role in motivating the

user to complete the entire prescribed rehabilitation

plan, [9], [10], [11], [12], [13], [14].

Identified the development opportunities, a

consortium composed of academic and I&D

research groups and technology-based companies

was established to develop and provide the market

with an advanced solution to support physical

rehabilitation – the ABLEFIT device. This device

combines a physical system to aid physical exercise,

in passive and active modes, in bed and a

wheelchair, and a control system for monitoring and

storing biofeedback variables and motivational

stimulus through interaction with gamification.

The following sections describe the evolution

process of the ABLEFIT device, from the design

and build of the prototype, going through the design

and construction of a second prototype based on the

results of the first pre-clinical tests, until the second

round of pre-clinical trials results that will give rise

to the commercial prototype that will be submitted

to clinical tests before being placed on the market.

Nevertheless, the two versions of the system built

and tested allow us to conclude that, not only the

limitations found in different technical solutions

available on the market have been overcome, but

also that the advantages gathered in a single solution

lead to full compliance with the individually

prescribed rehabilitation plan.

2 First Prototype of ABLEFIT

Fig. 1 shows the 3D CAD model of the prototype of

the ABLEFIT device. To ensure the different types

of movement to be performed in the exercises, two

modules (to be alternatively coupled to the device's

main structure) were developed as illustrated in Fig.

1: i) the linear module (Fig.1a)) that ensures the

performance of linear (e.g. flexion, extension) and

amplitude (linear movements with curvilinear paths,

such as adduction and abduction), or ii) the rotary

module (Fig. 1 b)), which ensures the performance

of rotational movements (e.g. internal and external

rotation).

Fig. 1: 3D CAD model of the first ABLEFIT

Prototype.

An easy-fit mechanism has been specially designed

for easy switching between the two modules, [17].

Any of these modules is activated by an actuator

that allows exercises in active mode (i.e., the

machine moves the user) or passive mode (the

patient makes the machine move). Actuator control

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ensures the incremental application of different

values of load, speed, and amplitude, to the

movements to be performed. Additionally, a

mechanical system was adapted to each of these

modules, allowing not only the use of the module

either by the feet or by the hands, i.e., any of the

modules can be used for rehabilitation plans applied

to the upper limbs or the lower limbs, but also the

possibility of using immobilization aids and fixing

parts of the limbs, as shown in Fig. 2 for the lower

limbs.

The suitability of the ABLEFIT device for

different types of beds and wheelchairs is ensured

by the vertical movement of the horizontal bar that

integrates the device structure. This movement is

controlled by an actuator that moves a threaded rod

attached to the horizontal bar. It ensures its up-and-

down movement (or stop) to adapt the device's

height to the type of exercise intended, regardless of

whether it is performed on a bed or in a wheelchair.

The Human-Device interface developed and

integrated into the ABLEFIT device ensures, in real-

time, the visualization, registration, storage, and

communication with other operating systems of all

biofeedback and training parameters of the patient,

e.g. peripheral blood oxygen saturation, heart rate,

blood pressure, force, velocity, time, etc. This

allows the continuous assessment of the evolution

and recovery progress of the patient. The

communication between the patient or caregiver and

the clinical team, if the patient does not have the

capacity and autonomy to do so or if the patient is in

a home environment, is also guaranteed by this

interface. In addition, the interface encourages

patients to practice certain exercises of the

rehabilitation plan through interactive games –

gamification – increasing the efficiency and

effectiveness of rehabilitation plans, since there is a

progressive increase in the motivation and

emotional involvement of the patients, [18].

The preliminary usability study presented in the

next section was performed to evaluate the

behaviour of the prototype built, namely regarding

its functionality, ergonomics, and safety, both from

the end users and the health professionals'

perspectives. The results and solutions presented in

sections 2.1 and 2.2 gave rise to the second

prototype of ABLEFIT (section 3). A human-

centered design was used, through a mixed-method

study, [19].

The pre-clinical research to explore usability

issues of devices under development is a mandatory

and important component of this type of research,

namely to assess safety (ISO/IEC Guide 63:2019)

and efficiency and efficacy parameters (ISO 16142-

1:2016).

In this sense, the pre-clinical phases focused on

human factors related to ergonomy and usability, in

compliance with the ISO 9241-210: 2010 and ISO

9241-11: 2018 regulations.

2.1 Pre-clinical Trials Results

Fig. 2 and Fig. 3 show the usability tests performed

respectively for the lower and upper limbs using the

linear module of the ABLEFIT device. Fig 2.

illustrates the knee extension/flexion movement and

Fig 3. illustrates the same kind of movement but for

the shoulder and elbow. Fig. 4 demonstrates the

rotational movement of the upper limbs.

Fig. 2: Usability tests using the linear module of

ABLEFIT for lower limbs.

Fig. 3: Usability tests using the linear module of

ABLEFIT for upper limbs.

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Fig. 4: - Usability tests using the rotary module of

ABLEFIT for upper limbs.

2.1.1 End-Users

A total sample of 10 older adults was recruited for

the study, with a mean age of 78.6 years. Criteria for

their selection were presenting a healthy physical

condition, with no mobility restrictions. Preferably

they could have past experiences as bedridden

patients. A pre-study questionnaire was performed

to prevent unavoided physical problems, like the

presence of ankle or knee prostheses. The same

rehabilitation program was executed for each

individual, after which he was asked a few questions

in a semi-structured interview to assess the

perceptions regarding the device’s usability.

2.1.2 Profissional-Users

A total of 12 healthcare professionals, with a mean

age of 37.5 years, were recruited to manipulate,

handle and assess the device’s functionalities. In the

end, the participants were asked to answer a

usability questionnaire, which provided a

quantitative score of the device’s usefulness. The

criteria applied for this group was having at least a

minimum of two years of clinical experience in the

hospital setting.

2.2 Identification of Drawbacks vs. Proposed

Solutions

For the first prototype, Table 1 and Table 2

summarize respectively the shortcomings identified

from pre-clinical trials and possible ways to solve

these limitations.

Table 1. Identified Limitations

OBSERVED PROBLEMS

Software

The definition of maximum and minimum positions

for active movements has no practical consequences

on the device’s behaviour.

When the program is interrupted for any reason, it is

not possible to resume it.

Hardware

Lack of structural stability.

Lack of structure resistance.

The hardship of linear and rotational module

assembly/disassembly.

The handle does not allow rotation during

movement, which poses a risk of injury to the wrist.

There is no support for the hand, which causes

movement instability.

Thigh and knee instability.

Table 2.Proposed Solutions

SOLUTIONS PROPOSAL

Software

Provide a limitation to the range of motion.

Include an option to resume the program, if needed,

at any time.

Cancellation must have an immediate effect on the

machine for security reasons.

Hardware

Redesign the structure to make it more resistant and

stable.

Develop a system to stabilize the hand throughout

the range of motion.

Develop modules for thigh and knee stabilization.

3 Second Prototype of ABLEFIT

Based on the observed problems and the solutions

proposed from pre-clinical trials, the second

prototype of ABLEFIT was designed and built as

shown in Fig. 5.

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Fig. 5: Second prototype of ABLEFIT device

It should be reported that this second prototype

guarantees the specifications already ensured by the

first prototype, i.e.: i) realization of customized

rehabilitation plans, ii) different types of movements

of the upper and lower limbs, iii) in active or

passive modes, iv) parameterization, telemonitoring,

visualization, recording, and individual storage, in

real-time, of the parameters prescribed in the

rehabilitation plan and biofeedback parameters, and

v) use of gamification methodologies to motivate

and encourage the user to comply with the

rehabilitation plan.

Regarding the shortcomings of the software

interface reported in Table 1, Fig. 6 illustrates how

they were overcome.

Fig. 6: Demonstration of the software

overcoming limitations identified in Table 1.

Concerning the identified hardware shortcomings,

the structure of the device was redesigned to

overcome the lack of stability and resistance

reported in the pre-clinical study by means of a

device frame (chassis) in a double T shape that

ensures robust structural support. The front wheels

are smaller in size to allow adjustment of the

equipment chassis under the hospital bed chassis.

The larger wheels integrate a central mechanical

braking system, which ensures the device's

immobilization during its use. In the future, this

mechanical system will be replaced by an

electromagnetic system.

The chassis was also designed to support two flat

sheets to which all the control and power

components of the device are connected, including

the Human-Machine interface. The fit device

positioning relative to the patient's positioning to

perform exercises is guaranteed by the two lifting

columns that can set the angle and height of the

linear or rotary modules. Additionally, the arm

where the linear module or the rotary module are

alternatively coupled has an electric linear actuator

to adjust the length of the arm according to the

patient's needs, that is, whether the exercises are

being performed by the upper limbs or by the lower

limbs.

Concerning the reported software limitations,

they have been overcome through i) the

implementation of upper limits for the range of

movements, ii) the possibility to resume, at any

time, the rehabilitation program following any type

of involuntary or forced interruption, and iii)

possibility to ensure the immediate stop of the

device for security reasons.

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3.1 Pre-clinical Trials Results

The second prototype was developed using the

feedback received from end-users, thus contributing

to person-centered care and medical device

development. The premises were the same used in

the pre-clinical trials for the first prototype.

3.1.1 Professional End-Users

Due to project time constraints and safety issues

regarding the newly developed prototype, only

healthcare professionals were invited to test the new

features. The same criteria as for the first pre-

clinical trials were applied.

3.2 Identification of Drawbacks vs. Proposed

Solutions

Table 3 and Table 4 summarize, respectively, the

shortcomings identified in the second prototype

from pre-clinical trials and the possible ways to

solve these limitations.

The software limitations identified will be easily

overtaken, given that they are confined to

programming adjustments and do not require new

developments. Concerning hardware enhancements,

such as easy and fast interchangeability between

rotary and linear modules or an improvement in the

device´s compactness and portability –so that it can

be easily placed in any hospital, clinic, or home

environment–, they represent challenges that still

require further development, optimization, and

implementation work. Furthermore, the

development of auxiliary systems to the ABLEFIT

device is imperative to ensure the necessary support

and stability for both the lower and upper limbs

during the execution of movements in order to avoid

unwanted injuries. In addition, the device placed on

the market cannot include loose cables or sharp

edges. As such, several improvements are still

required to the architecture of the device as well as

the development of flexible components to increase

usability, safety, and easy cleaning. Finally, issues

like energy efficiency, noise reduction, and the use

of recycling materials will be accounted for to

provide a low-cost rehabilitation device.

Table 3. Identified Limitations

OBSERVED PROBLEMS

Software

Regular screen blackouts/instability.

Touchscreen requires external devices to work.

Unable to save previously inserted data regarding

patient and program development.

Hardware

Easy and fast interchangeability between rotary and

linear modules.

User-friendly operability.

Compactness.

Ease of cleaning.

Portability.

Low cost.

Use of recycling materials.

Autonomy.

Energy efficiency.

Cable fixing.

Noise.

Table 4. Proposed Solutions

SOLUTIONS PROPOSAL

Software

Provide more details in the graphical display.

Offer a more user-friendly touchscreen (e.g.,

adequate size of options and fonts).

Hardware

Reduce the device’s size so it can be easily placed in

any room.

Develop flexible components to increase usability

and safety.

Develop an extra component to accommodate the

patient’s upper limb or lower limb, while moving it

or in a resting position.

Hide the cables inside an architecture, and avoid

sharp edges.

4 Conclusion

To minimize the negative impacts of the PIS

phenomenon on individual health and the social

component and economic impact, a group of

academic and business entities comes together to

jointly develop a technical solution that responds to

identified market failures with that respect.

This technical solution – the ABLEFIT device –

provides customized physical exercises, in active

and passive modes, for patients permanently or

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temporarily bedridden or in a wheelchair. The

device incorporates an intelligent platform for

control, evaluation, and record of the patient’s

performance during the rehabilitation process,

making possible the permanent assessment of the

patient’s status and thus contributing to an

integrated knowledge of their condition by health

professionals. Furthermore, it is also possible to

generate simulation environments and create

interactive models to stimulate and motivate the

user.

A feasible contribution is thus expected to

counteract the immobility syndrome and the

morbidity and mortality associated with the

complications resulting from prolonged inactivity or

even a sedentary lifestyle that can be seen both in

the elderly population and in adults and young

people with some type of restriction of mobility or

disability. Nevertheless, a third iteration is still

required to overcome the limitations reported in the

results of the second pre-clinical test. As such, a

third prototype will be built, which will undergo

rigorous clinical tests before being placed on the

market. These results will briefly present.

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Contribution of Individual Authors to the

Creation of a Scientific Article (Ghostwriting

Policy)

-Rafael Bernardes, Vítor Parola, Remy Cardoso,

Hugo Neves, and Arménio Cruz were responsible

for the execution of pre-clinical tests and for paper

writing.

-William Xavier was responsible for the execution

of human-machine interfaces of both the first and

second prototypes.

-Rúben Durães was responsible for the execution of

the second prototype.

-Cândida Malça was responsible for the execution

of the first prototype and for paper writing.

Sources of Funding for Research Presented in a

Scientific Article or Scientific Article Itself

This research was co-financed by the European

Regional Development Fund (ERDF) through the

partnership agreement Portugal 2020 Operational

Programme for Competitiveness and

Internationalization (COMPETE2020) under the

project POCI-01-0247-FEDER-047087ABLEFIT:

Desenvolvimento de um Sistema avançado para

Reabilitação.

Ethics

The study was approved by the Ethical Committee

of the Health Sciences Research Unit: Nursing

(UICISA:E), from the Nursing School of Coimbra

(ESEnfC), reference nº P879_05_2022.

Conflict of Interest

The authors have no conflict of interest to declare.

Creative Commons Attribution License 4.0

(Attribution 4.0 International, CC BY 4.0)

This article is published under the terms of the

Creative Commons Attribution License 4.0

https://creativecommons.org/licenses/by/4.0/deed.en

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