Recent developments in robot-mediated rehabilitation have shown the potential of robotic devices for delivering repetitive training, thus allowing for a large number of repetitions to be delivered during chronic phases of stroke rehabilitation.
The first SCRIPT Passive Orthosis prototype (SPO) is a wrist, hand and finger orthosis that is intended to assist individuals after stroke that suffer from impairments caused by spasticity and abnormal synergies. These impairments are characterised in the wrist and hand by excessive involuntary flexion torques. The objective is to use the passive orthosis towards extending the wrist and fingers against the involuntary flexion.
The SPO prototype can passively offset these undesired torques, but it cannot actively generate or control movements. The user needs to use voluntary muscle activation to perform movements and thus needs to have some residual muscle control to successfully use the SPO. It applies the external and manually adjustable extension torques via passive leaf springs and elastic tension cords.
The SPO is equipped with sensors to measure the joint rotations and applied forces/torques. It also provides limited information on the user's forearm posture.
The SPO is a part of the SCRIPT (Supervised Care & Rehabilitation Involving Personal Tele-Robotics) project which mainly aims to provide motivational, cost-effective and more enjoyable therapy sessions at home in order to contribute to the personal independence for stroke patients. The patient benefits from a graphical user interface which can transform the mundane and repetitive therapeutic exercise into an interactive and adaptive exercise using sensory feedback and games. The games are designed to adjust the difficulty level based on performance assessment while allowing them to provide a view into the history of game-play scores and performance (e.g. number of repetitions and range of motion over time). The patient interface facilitates the assessing of interaction prior to exercise and for immediate feedback after the exercise. A remote health care professional interface allows the therapist to set the exercise routine remotely and to observe the patient’s progress throughout his/her exercise programme. The two interfaces also provide a chance for message (textual and audio) exchange between the patients and their therapist, including guidance and feedback messages.
The SPO is currently under clinical evaluation for assessing its feasibility and identifying the potential effects of having a SCRIPT device at home. Evaluations take place concurrently in the Netherlands, Italy and the United Kingdom with an intention to evaluate the system with 24-27 stroke patients in a home trial lasting 6 weeks.
The design of a second prototype with active-tuning of assistance forces is underway, aiming to provide automatically adjustable levels of assistance. This prototype will be also be clinically evaluated during the third year (Nov 2013 – Oct 2014).
The project aims to use both evaluations to support a business case for home-based rehabilitation mediated by script prototypes.
The SCRIPT Project is partially funded under the 7th Framework Programme by the European Commission. It is developed by 8 organisations of 4 European Countries (Germany, Spain, the Netherlands and the United Kingdom).
Description of target users and groups
Patients that have suffered a stroke and are in the rehabilitation phase and healthcare professionals responsible for their care.
Description of the way to implement the initiative
The project’s implementation is structured through the following work packages:
1. Develop an understanding of potential users of the devices and the context in which the system operates.
2. Identify and refine understanding of the needs of range of potential users of the devices.
3. Determine and establish a framework for user engagement in design and system development through user input during formative evaluations.
WP2 Objectives: Develop a wrist-and-hand therapy device for neurologically impaired limbs. Optimal results will be achieved with a device design which inherently does not impede natural or remaining motion of the wrist and hand and only supports it where needed. This is to be realised using a passive actuation mechanism.
WP3 Objectives: Integrate active assistance or active adjustment of the passive actuator (for instance by integrating low-power electric motors) into the passive hand-and-wrist orthotic device from WP2. This enables better control over the assist-as-needed characteristics of the device and, if so desired, can also generate haptic interaction with a virtual world.
WP4 Objectives: Develop the user interface for the hardware and software for both patients and therapists. The user interface will guide patients through sets of exercises while providing various elements of feedback to encourage and inform the patient. Similarly the system will provide the therapist with a range of performance metrics and historical trends so that a patient's progress over a period of time can be assessed. The system will also allow therapists to set up exercise regimens for patients which can then be downloaded to the equipment used by each patient. Similarly, the system will allow upload of performance data from the patient equipment to the therapist system.
WP5 Objectives: Research and develop the platform that supports the patients in their home training and supports the clinicians in providing the patients an effective remote coaching. This includes research and technological development in the area of interfacing the exercise systems to get relevant physiological and biomechanical parameters and their processing to obtain relevant features to allow for quantitative remote management of therapies.
WP6 Objectives: Develop new models for therapeutic human-robot interaction. Baseline for this interaction is the kinematic minimum jerk hypothesis, which is capable of producing smooth trajectories for interaction. This has been extensively used to reproduce the passive, active-assisted and active interactions. However, this work packages aims at investigating a true adaptive interaction where different models such as energy flow or lagging-leading models can be used to determine the extent of help required in achieving tasks with therapeutic benefits.
WP7 Objectives: Provide a framework for seamless integration of software and hardware components. These include both therapy devices alongside software for interaction, user interface for activity selection and performance assessment, tele-supervision and data security components. This WP is also responsible to ensure clinical partners will receive working hardware and software with adequate training prior to the start of each summative phase of the project. Moreover, it frequently seeks news benchmarks and outcome parameters for device operation and interaction quality.
WP8 Objectives: Assess the differential impact and added value of a passive and active system for independent hand/wrist exercise at home on clinical, user acceptance (including usability, satisfaction, motivation and compliance) and economical aspects:
1. Assess whether post-stroke arm/hand training at home improves arm/hand functionality.
2. Assess which training modality (passive/active system) improves arm/hand functionality most.
3. Examine whether stroke patients increase their total amount of practice when provided with the opportunity.
4. Examine whether additional training enhances changes in arm/hand functionality, and which factors contribute to this.
WP9 Objectives: impact actions of the project. Dissemination activities are aimed at maximising the benefit of the public information generated by the project as well as raising the awareness regarding the efficacy of the system and approach with potential users and other stakeholders. The main dissemination actions will be through a dedicated website, publication of papers in refereed journals and presentation of 2-3 papers at international conferences and relevant workshops (per partner).
WP9 Objectives: Provision of the necessary structure required to support contractual, financial, administrative and technical project management activities.
A common framework for software and hardware integration has been employed from the start of the project. This involved setting up a project SVN server and establishing a common understanding for record keeping and versioning different hardware and software design iterations. A part of this includes a common prototype assignment where each integration phase results in a system prototype that does not change throughout any of the summative phases of the project. In addition the choice of operating system, programming languages and interoperability, common data storage mechanism, and common visual rendering requirements are considered.
The project team acknowledges that essential for its implementation in daily clinical practice, is the integration of the data into hospital/clinics, so that caregivers can use it as a single system and the relevant data comprised in a specific report format can be integrated automatically within the hospital context. Therefore a dedicated work package explores existing open platforms for electronic medical/health records and will incorporate existing developments in this area towards secure and confidential remote interaction between patients and clinicians.
The project focuses on usable interface development driven by the end user’s formative design and evaluation cycles. This aspect alongside remote management and issues of security and confidentiality are considered within the context of the three partner Member States (the United Kingdom, the Netherlands and Italy), thus allowing for identifying interoperability issues within a European perspective, as well as the expected user base in each partner country.
Use of Standards: During the first period, preparation of the protocol for ethical application was progressed. This included provision of information regarding a medical device for investigational purposes, also referred to as IMDD (International Medical Devices Dossier), a newly added part of the Medical Research Ethics (MEC) committee in the Netherlands. These additional requirements involve information about technical aspects and safety issues of a newly developed device, as is the SCRIPT system, which can potentially result in a certified medical device. Requirements included risk assessment for all components, as well as user manuals. The required information was gathered and an ethics application was granted by MEC in the Netherlands and subsequently by our Italian and UK partners.Technology choice: Proprietary technology
Main results, benefits and impacts
The SCRIPT project goals are:
- Use specialised technologies at patients’ homes, enabling better management of chronic stroke as they allow larger repetitions and frequent exercise which can in turn increase the recovery gains. Moreover, they allow objective database of performance for tailoring treatment and follow-up;
- Focus on hand and wrist exercises that present the least researched area with the most functional relevance, and potential for contribution to personal independence;
- Look at differences between passive and active actuated devices. The inherent safe nature of these devices makes them an ideal choice for home use;
- Provide an educational, motivational and engaging interaction, which makes a therapy session more enjoyable, while having the capabilities to provide feedback to patients and health professionals. The feedback provided will be based on heterogeneous data collected during interaction as well as comparisons with models such as minimum jerk model as a performance indicator;
- Focus on remote management and support of the patient. The project creates a communication platform that will support, remote management allowing to remotely adjust the therapy programme, thus reducing hospital or home visits. This is facilitated by incorporating the clinical workflows into user interfaces used by patients and clinicians while maintaining a customisable and easy to operate front-end for users. The two-fold objective here enables to look at aspects of acceptability and compliance as well as data security and confidentiality;
- Infer from a complete evaluation in this project, impact on health and recovery and its potential cost implications.
Project progress (as of March 2013):
In year 1 the project delivered the first prototype system, which is based on a passive actuated device. It allows stroke patients to play three games for wrist and hand rehabilitation at home. Year 1 of the project encompassed the formative evaluation cycle, which provided a user-centred design approach during shaping of the first prototype system. This included the hand and wrist orthosis and different software components such as patient user interface and health care professionals user interface. Stakeholders involved in these formative cycles included patients, family carers and therapists via a number of focus groups across the UK, the Netherlands and Italy. Furthermore, prototypes underwent usability and home-based testing.
The resulting system adapts the exercise to the individuals’ needs, i.e. in form of speed and range of motion available and allows the therapist to remotely monitor the activity through a web portal. Games are specifically designed to link the exercise with their therapeutic benefits, i.e. increasing the range of motion or speed in achieving different gestures such as grasping or flexion and extension of the wrist.
During year 2 this system will undergo summative evaluation with 24-27 participants across the three countries (the United Kingdom, the Netherlands and Italy) who will participate in a six-week study. In the meanwhile a new version of the device (the active actuated one) will be developed taking into account the formative evaluation of the first prototype. Additionally, four more games will be developed to allow for more diverse set of exercises and more engaging opportunities.
Return on investmentReturn on investment: Not applicable / Not available
Track record of sharing
The SCRIPT project attended and presented at a clustering event on 23 October 2012. The event was attended by a group of projects in the same cluster with similar development objectives and was organised by the DG Connect, Unit H.1 “Health and Well-being”, overseeing the execution of these projects. As a result of this event, the project is currently working with the REWIRE project that develops, integrates and field tests an innovative virtual reality-based rehabilitation platform system based on a multi-level rehabilitation platform. We have proposed a confidentially agreement in order to share information related to similarities within our work.
The project has developed a partnership with Saebo Inc. and signed a non-disclosure agreement. Saebo provides innovative rehabilitation products for individuals suffering from neurological injuries such as strokes. We are currently using the Saebo Mas product to work with our device and feel a partnership with Saebo offers potential to learn from a leader in the field.
We have established an external advisory committee of key industrial stakeholders in the field. This group of three experts are on hand to offer advice on how best to transfer project results to the wider community via positive exploitation.
A wide range of dissemination activities have taken place towards public and stakeholder engagement. As an example, during current year, a workshop and a talk was organised at the International Neurorehabilitation Symposium (INRS 2013 in Zurich, Switzerland on 11-13 September) and a demonstration is planned in Vilnius (ICT 2013 - Create, Connect, Grow, in Vilnius on 6-8 November 2013). Other dissemination activities include project publications in international conferences such as ICORR2013 (International Conference on Rehabilitation Robotics) and dissemination via four journal papers submitted to peer-reviewed scientific journals in the areas of health care and rehabilitation.
The project is in a continuous interaction with the COST European network on Robotics for neuro-rehabilitation (TD1006), where bi-lateral activities support the project and COST network objectives.
The following three lessons reflect on the first two years of the project:
- The project realised a total of 11 prototype devices during the first 14 months. This was possible with extensive planning and extraordinary commitment of the consortium.
- Recruitment of patients in three different countries provided a challenge to project timelines, especially given that a new set of ethical rules came into force after the preparation of the description of work and contract negotiations. Contingency planning proved a useful consideration for minimising delays.
- Alignment with the COST network in Neuro-rehabilitation provided a chance to echo the findings of the project in multiple events organised by COST and attended by large stakeholder parties, while project partners assist the COST network in different activities of the network.