Requirements and Conceptual Architecture

Reaching movement


A327370_1_En_2_Figb_HTML.gif Grasping movement

Therapists and patients found a text area for therapists’ comments useful, as therapists could provide further tailored feedback and encouragement to patients. Finally, the later prototypes of the SMART system were developed with a minimum number of buttons and options. Buttons had to be large, easy to view and colour coded with themes.



2.1.4 Exercise Prescription


Patients and therapists felt that a home-based system could create a danger of allowing patients to have too much exercise, which can be demotivating and stop them from using it. There has to be a balance between protecting the stroke patient and not progressing their rehabilitation and giving too much exercise that is directly unsupervised.


2.1.5 Feedback on Progress (and Interface Design of Feedback)


The majority of patients described this as one of the most important factors in adhering to the exercises. The first prototype of the system used graphs as feedback. Patients did not find this helpful and required a simpler visual feedback system. Patients opted to see a ‘target movement’ next to their own movement. This allowed them to see how close their upper limb exercises were compared to an ideal movement. The smart system used a 3D graphic of a target movement, which was generally well received. One prototype of the system allowed patients to view the target movement and their own movement from three angles; however, patients found this unnecessary and overly complex. Patients agreed that they wanted an objective score of their movements and rehabilitation progress in addition to a display of their previous attempts over time. Finally, some patients reported that they would like the option to record their own notes. In the event of a fall at home or illness, they wanted a method to see if adverse conditions meant their rehabilitation was more difficult than usual.


2.1.6 Outcome Measures and Compliance


Patients and therapists felt that all outcomes must be relevant to restoring upper limb function and activities of daily living as opposed to directly addressing impairments. The researchers found that displaying visual prompts to remind the patient to don the sensors was helpful to increase adherence. Patients also found providing a list of FAQs and a user manual with images and instructions of how to use the system helpful to aid their memory. Giving patients an example of the sensor output on the screen helped them to know if the system was working, and that they had donned the sensors in the correct position and on the correct limbs. In addition, colour coding the sensors for donning on the left and right arms helped to increase adherence to wearing the body sensors. Both patients and therapists felt engagement of family and/or carers in the development of any home-based rehabilitation system was vital, as they will often assist patient to do rehabilitation.



2.2 Clinical Specification of the System


The StrokeBack system will consist of two parts:

1.

‘Expert clinical system’ that in principle is hosted in a hospital, though it could be also portable, which requires expert user to set up for detailed studies and clinical knowledge for the assessment of a patient.

 

2.

‘Home-based system’ that is much simpler and easy to use, allowing it to be set up by non-experts, e.g. family members or caretakers.

 

The StrokeBack system is specific to upper limb rehabilitation and has been developed and tested during the performance of a subset of the ‘Wolf Motor Function Test’ (WMFT). The activities will encompass a wide range of levels of ability and functional tasks. The system generates extra impairment level data including: spasticity/stiffness, motor control, speed, smoothness, repeatability, fatigue and endurance, as well as effort put in.

The fundamental principle of the expert system is to become a diagnostic tool for the identification of key impairments, identified by analysis of data generated during the performance of standardised tasks. It offers a method of activity prescription. It consists of a BAN of external sensors, e.g. cameras with an aim to collect large amounts of rich highly informative data for real-time data analysis. Both real-time feedback and power consumption were not critical in this case.

The fundamental principles of the home-based system were the usability as a key to user adherence to prescriptions. The system was expected to be minimalistic and utilise a subset of the sensors allowing patients to easily interact with workstation activities. In this case, power consumption is critical, as well as the real-time data analysis and presentation.


2.2.1 WMFT Tests


The WMFT was chosen to test patient’s ability to perform everyday tasks using household items—being suitable for patients to perform in their homes as well as in clinic. Such tests are sensitive to a wide range of abilities; they are standardised, validated and widely used.

They enable characterisation of functional movement—i.e. not simply joint ranges and permit correlation with test-score as validation of sensor data while score can be used to prescribe rehabilitation and give feedback.

The WMFT scoring scale selected by therapists with each individual task or exercise was given a numerical value defined from:



  • 0 = when patient does not or is unable to attempt with the involved arm


  • 1 = when the involved arm does not participate functionally and the task is not achieved; however, an attempt is made to use the arm


  • 2 = when arm does participate and the task is achieved, but movement is influenced to some degree by compensatory movements and/or abnormal movement patterns or performed slowly and/or with effort


  • 3 = when arm does participate and the task is achieved in one attempt; movement is close to normal but slightly slower; may lack precision, fine coordination or fluidity


  • 4 = when arm does participate; movement appears to be normal, timely (pay attention to expected normal times) and controlled


2.2.2 Sensors, Data and Metrics


Sensors were selected to measure movement (accelerometers, rate gyros, magnetometers), electromyogram (EMG) and possibly include also heart rate and respiration as measures of physical activity and effort. Sensor data were to be used for determining conventional metrics such as joint ranges, velocity and acceleration. More meaningful metrics related to normal movement patterns will also be determined, e.g. trunk movement during reaching, symmetry, accuracy of performance and smoothness as well as the correlation of WMFT data with the clinical score—‘assessor-free’ measure of function.


2.2.3 Design Overview from Clinical and User Perspectives


A decision-making system presents suggestions to the patient about activities to practice that are appropriately challenging, address-specific impairments, goals and interests. These suggestions were classified as exercises and ADL.

Basic principles were for patients to choose activities that they want to practice from an appropriate targeted range and then allowing patients to sets their own targets for each day or for the longer term. Patients become more motivated because they have chosen their activities and feel more in control and responsible. In conclusions of clinical, the system specification included:



  • Self-management as key to patients—locus of control [8]


  • Motivation and fun as key to ensure adherence and achieving benefit


  • Designed to achieve realistic goals


  • Intensity of exercises targeted to individuals based on results assessment


  • Reaching ability level near normal operation is likely to be maintained


  • Offering an intelligent progression of tasks and activities


2.3 Ethical and Privacy Protection Regulations and Directives


One of the most controversial issues for PHRs is how the technology could threaten the privacy of patient information [9]. Network computer break-ins are becoming more common, thus storing medical information online can cause fear of the exposure of health information to unauthorised individuals. In addition to height, weight, blood pressure and other quantitative information about a patient’s physical body, medical records can reveal very sensitive information, including fertility, surgical procedures, emotional and psychological disorders, diseases, etc. Various threats exist to patient information confidentiality, example of are:



  • Accidental disclosure: during multiple electronic transfers of data to various entities, medical personnel can make innocent mistakes in its disclosure.


  • Internal leaks: medical personnel may misuse their access to patient information out of curiosity, or leak out personal medical information for profit, revenge or other purposes.


  • Uncontrolled secondary usage: those who are granted access to patient information solely for the purpose of supporting primary care can exploit that permission for reasons not listed in the contract, such as research.


  • External intrusion: Former employees, network intruders, hackers or others may access information, damage systems or disrupt operations.

Unlike paper-based records that require manual control, digital health records are secured by technological tools. Rindfleisch [6] identifies three general classes of technological interventions that can improve security:



  • Deterrents—These depend on the ethical behaviour of people and include controls such as alerts, reminders and education of users. Useful form of deterrents is Audit Trails, recording identity, times and circumstances of users accessing information. Users aware of such a record keeping system are discouraged from taking ethically inappropriate actions.


  • Technological obstacles—These directly control the ability of a user to access information and ensure that users only access information they need to know according to their job requirements. Examples of technological obstacles include authorisation, authentication, encryption, firewalls and more.


  • System management precautions—This involves proactively examining the information system to ensure that known sources of vulnerability are eliminated. An example of this would be installing antivirus software in a system.

The extent of information security concerns surrounding PHRs extends beyond technological issues. Each transfer of information in treatment process must be authorised by patients even if it is for their benefit. No clearly defined architectural requirements and information use policies are yet available. While the trends and developments of ICT in healthcare have given rise to many positive developments, concerns about the use of ICT in user services mainly concentrate on the difficulty of respecting privacy and confidentiality when third parties may have a strong interest in getting access to personal health data electronically recorded and stored and difficulty in ensuring the security of shared personal data [10].

Therefore, the project is dedicated to respecting and protecting the personal data, considered as extremely sensitive since they refer to the identity and private life of the individual. It recognises the intent to create a potential for the circulation of personal data across local, national and professional borders, giving such data an enhanced European dimension, while respecting the principles of the European Convention of Human Rights, the rules of the Convention of the Council of Europe for the protection of individuals with regard to automatic processing of personal data and especially the European Directive 95/46/EC, for the protection of personal data will be strictly followed when addressing ethical issues.


2.3.1 Involving Adult Healthy Volunteers


Potential ethical issues that are addressed in this research will involve end-user interviews, questionnaires and trialling of prototype systems during the development and testing. The right to privacy and data protection is a fundamental right, and therefore volunteers have the right to remain anonymous and all research will comply with Data Protection legislation as to ICT research data related to volunteers.

During our research, only participants who have sufficient cognitive and physical ability to be able to safely participate and clearly give informed consent are asked to participate. Potential ethical issues arise from the fact that participants, especially those who may tire easily or become distressed. Ethical issues may also arise when the system is used to give participant location or well-being information to third parties. Here, release of this information is subject to informed consent of participants, and subject to the ethical frameworks to restrict knowledge of this information to only those given consent.

All participants in the research are volunteers enrolled from the end-user groups connected with this research, and all ethical criteria are supervised by ethicists. At all times, participants are ensured privacy and technical platform managing private user data is fully geared to enforce ethics.


2.3.2 Tracking the Location of People


Tracking the location of people is tightly linked with services delivered at the location of the user. This requires new look at the new socio-legal issues they raise. In the developed system, we only consider laws applicable to protecting privacy of the general population and NOT the laws and regulation specific for the case of the employee tracking and localisation.

The European legislation has adopted specific rules requiring that the consent of users or subscribers be obtained before location data are processed, and that the users or subscribers be informed about the terms of such processing. The rule is that the applicable law is that of the Member State where the ‘controller’ is established; and not that of the Member State of which the data subject is a national. ‘If the controller is not established in a Member State, and in that case data protection laws of the third country should be found adequate by the EU-Commission’ [11].

Location data collection will be in accordance with some basic principles: finality, transparency, legitimacy, accuracy, proportionality, security and awareness. Access to location data must be restricted to persons who in the course of exercising their duties may legitimately consult them in light of their purpose. The relevant laws include:



  • Directive 95/46/EC: Protection of individuals with regard to processing of personal data and free movement of such data [12]


  • Directive 2002/58/EC: Processing of personal data and protection of privacy in electronic communications [11]


  • Directive 58/2002/EC of the European Parliament and of the Council of 12th July 2002 [13]

Processing of personal data and the protection of privacy in electronic telecommunications sector is governed by:



  • Directive 97/66/EC: Data Protection in the Telecommunications Sector [14]


  • Directive 99/5/EC: Radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity [15]


  • Art. 29—Data Protection Working Party: Working Document on Privacy on the Internet [16]


2.3.3 Specific Approaches Adopted


The consent of users or subscribers shall be obtained before location data needed for supplying a value-added service are processed. Users or subscribers will be informed about the terms of such use. Access to location data must be restricted to persons who in the course of exercising their duties may legitimately consult them in the light of their purpose. All required user profile data are stored upon his/her mobile device and be securely protected.

Relevant preferences relate to his/her diet, physical activities, dietary or transport/tourism-related preferences, and, in general, simple everyday task preferences will not be stored locally. The user will have the capacity to view/hear, change or delete, as he/she wishes, all stored data by the system (including his/her profile data), with the help of a very simple and multimodal interaction (touch, buttons and voice input supported).

Types of data to be retained under categories identified in Article 4 of Directive 95/58 of 12th July, 2002. Specific safeguards—issues considered by the Article 29 working parties to be addressed with regard to the retention of data processed in connection with the provision of public electronic communication services (21st October 2005 opinion on the same subject directive proposal issued by the EU Commission on 21st September 2005).


2.4 Authentication and Authorisation


Authentication and authorisation are two main means for allowing access for the user to a resource. Authentication involves such issues like identifying the user by means of either a simple login/password check to elaborate biometric analysis involving fingerprints, retina scans and voice and/or face recognition. Authorisation then performs checks whether a given user may be granted access to a given resource or not.

Such processes have been part of any secure system from the beginning of computing systems. Their complication has increased recently with the rapid growth of the amount of information resources and number of user accounts in each system, platform and/or network. This increases network administrators’ work on properly securing their network and databases against unauthorised access at the same time providing users’ with uninterrupted access to resources that they should be authorised to access.

However, currently employed methods for performing authentication and authorisation, in most cases, require user authentication every time he moves between resources stored on differently protected sites causing annoyance and loss of time. On the other hand, approach to authorising users based on user-resource association requires tedious administrators’ job to properly secure access to different resources and gives rise to frequent faults when users are either authorised to access resources that they should not have access to or not being able to access those that they should be able to.

This problem has been identified and addressed in almost all the systems since long time [17]. Administrators are offered means for specifying access rights per-user group, policy definition mechanisms and macros allowing them to simplify management of access right to both existing and new users. Despite the fact that these tools are used, the problems of authentication and authorisation still contain loop holes attributed mostly to human errors than to machine security as such. Our proposed seamless authentication and authorisation is aimed to simplify further the process of securing access to multiple-interconnected systems as well as making authorisation less prompt to faults.

Authentication is the process of authenticating a user across multiple account protected resources and platforms, i.e. agreeing between different authentication authorities means of establishing trust relationships and dependability for transferring users authentication status, i.e. checking that a user is who they claim to be. The process will include customisation of means of authentication whereby users will not be required to perform authentication while transferring from one trusted party to another using single authentication.

In the case of moving from a party with lower authentication requirements to one requiring higher level of authentication, user will only be required to perform extra security checks while accessing differently protected resources instead of performing the whole authentication process from the beginning. Approaches like this have been already proposed, most known being Windows Passport or Live Account [18], where user may move between sites that support this technology. However, such methods do not take into account differences between authentication means required by different sites. This limits applicability of technologies to social websites aiming to keep a record of users accessing their services.

Authorisation in computer terms refers to granting access to a resource to a given user. In most computer systems, granting access is related to belonging to a specific user group meant to allowing administrators defining single access rights rules for a group of users. However, this makes it very difficult when it comes to more per-user access granting, especially in systems with large number of user accounts. What we propose is to unify and simplify means of granting user access to given resources.

The process will define sets of resource authorisation dependencies whereby access to one resource may be implicitly granted upon prior-assigned access rights to another resource. This will allow removing the need for the security administrator to provide access rights to every user to every resource, instead concentrating on defining security interdependencies between resources and defining user access right only to key global resources. Note that this will not remove a possibility to explicitly grant or block access to a given resource to a given user, if required.


2.5 Concept Platform Architecture


The PHR platform developed internally by Intracom S. A. Telecom Solutions, name intLIFE, has been enhanced and geared to diverse health application through a number of FP7-funded research projects, such as Artemis-CHIRON [19], ICT-PSP-NEXES [20], AAL-PAMAP [21], FP7-StrokeBack [22] and FP7-ARMOR [23]. Special adaptations have been geared to allow safe sharing of patients’ clinical data with appropriate measures, as described earlier, for the protection of private data, ensuring controlled access to it while ensuring that any data distributed cannot be traced back to the person from whom data has been taken from. This way a medical system based on PHR system could be safely applied for the purpose of deriving clinical models build from large amount of data for subsequently allowing more reliable feature-based clinical diagnosis on other patients and detection of conditions not possible earlier. In order to provide necessary privacy and security safeguards EHR/PHR, Vital Signs Monitoring and Management subsystems are all connected via secure and encrypted interfaces controlled via authentication, authorisation, and anonymising modules.

Only gold members can continue reading. Log In or Register to continue

Stay updated, free articles. Join our Telegram channel

Sep 25, 2016 | Posted by in PHYSICAL MEDICINE & REHABILITATION | Comments Off on Requirements and Conceptual Architecture

Full access? Get Clinical Tree

Get Clinical Tree app for offline access