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FP7

PUMA Report Summary

Project ID: 315114
Funded under: FP7-SME
Country: Denmark

Final Report Summary - PUMA (Development of a non-invasive and portable tissue viability measurement and intelligent actuation system for the prevention and early detection of Pressure Ulcer risk at Tetraplegic SCI users)

Executive Summary:
The PUMA project has allowed the development of an integrated system to support the prevention of pressure ulcers in T-SCI users. The main components of this system are tilting-in-space wheelchair, a monitoring system (pressure, temperature, humidity and tissue viability parameters), a dynamic cushion and a electrostimulation system. PUMA system has been designed allowing its scalability and modularity, with the possibility to configure six different results as detailed below:

• R1: Smart Short, embedding the different tissue viability sensors and FES electrodes in an electronic-textile short and a cushion case with the pressure sensors.
• R2: Dynamic actuation system composed of the integration of tilt-in-space wheelchair and dynamic pressure cushion.
• R3: FES Control for adjusting the parameters for muscular and vascular stimulation based on measured tissue viability for T-SCI.
• R4: Risk Measurement Control,being the brain of the system receiving the measurement data from the smart short and cushion case, assessing the risk of developing a PU.
• R5: Actuation Control for managing the repositioning movements of the dynamic actuation system and dynamic cushion according to the PU development risk assessment.
• R6: PUMA System is the global product, which is composed of the integration of R1 to R5.

Formally the work was structured around nine WPs. In the first two WPs we have focussed on obtaining the user’s needs (WP1) and the translation into product requirements (WP2). WP3, WP4 and WP5 have been devoted to the development of the main three sub-systems: smart pants with sensors and FES (WP3), tilting-in-space and dynamic cushion (WP4) and the control system (WP5). Under WP6 we have worked into the integration of the different sub-systems while in WP7 we have run the different validation processes and tests. WP8 has focused on the dissemination and exploitation activities. At this moment the patent procedures have been initiated and the coordinator of the project is in an advanced state of negotiation with an investment fund group to go further into the development and to define and stablish a strategy for the “going to market” step.

The consortium has eight partners with well-defined roles as can be seen below:
• Qimova is a wheelchair manufacturer and has leaded WP8 on dissemination and exploitation activities.
• BerkelBike had an electrostimulation system. With this project it has been updated and now it would be possible to sell it as a component of PUMA system and also as a separated product.
• SensingText is an SME expert in the development and commercialization of smart textiles, its work in this project has been focused on the development of the pressure sensors
• IBV is a RTD centre, its work in this project has been focused on the development of the mechanical wheelchair components, the interface of the control, and the measurement and analysis of the signals related to the tissue viability of the body. Additionally IBV has supported the development of the methodologies used to include the users in the different phases of development of the project and in the validation of the system from a mechanical and manoeuvrability point of view.
• EII is a RTD centre, its work in this project has been focused on the development of the control of the different subsystems and their integration.
• CTB is a RTD centre with main campus of expertise related to textiles. CTB has worked on the development of the different textiles and specifically in the development of the “smart pants”

• HUHNPAIN, the Paraplegic Hospital of Toledo, as it is known commonly this lead center on SCI treatment, has work hard in the definition of the system requirement from a clinical point of view, and the validation of the system with “real users”.

• VL, Via Libre, is a SME working in the field of orthopaedic and assistive devices distribution in Spain. Its main role in this project has been to introduce the commercial vision from a point of view of a dealer.
Project Context and Objectives:
Approximately 85% of Spinal Cord Injury sufferers (SCI) relying on wheelchairs (380.000 in Europe) and with over 11.000 new cases each year will develop a Pressure Ulcer (PU) during their lifetime. Suffering a PU leads to the following negative impacts such as deterioration of health, Social exclusion and reduction of independent living. Direct costs involved treating PUs in SCI sufferers exceeds €2 Billion per year, counting up for 10% of the total costs involved treating Pus.

PU are localized injuries in the skin and/ or underlying tissue initiated by a sustained impaired blood flow. An excessive or time extended pressure, shear or friction as usually occurs over the bony prominences leads to an impaired circulation of the blood flow. SCI sufferers do not dispose of the natural mechanisms that prevent the formation of PU such as the sensory perception, the ability to perform postural and alterations in the Autonomous Nervous System (ANS) reducing the natural mechanism of hyperaemia as well as of a healthy baseline condition of the vasomotor system

While 95% of all PUs are considered preventable, no concluding evidence exists that current devices are effective in the prevention of PU. In fact, 38.5% of PUs appeared while using any of these preventive devices.

Current solutions, from manual postural changes to dynamic pressure release devices, do not effectively prevent the development of PUs as they seems to rely on reducing and relieving pressure without real feedback control to patients when they are in danger of developing a PU and apply strategies without considering the user and context.

Suffering a PU affects negatively health, needing additional surgical interventions or longer recovery times, constituting even a deadly threat due infections; derive in social exclusion due to odours and pain; and reduce the time being able to spend sitting limiting independent living, leading all to a reduction of Quality of Life. Between one third and a half of all SCI sufferers will develop a PU in the first five years of their trauma and 7-8% will eventually die of complications

Treating PUs are difficult, costly and risky to patients. However, prognosis is excellent at early stages, PUs usually heal then by themselves once the pressure has been removed. Therefore, prevention and early detection are the main priority with PUs. While 95% of all PUs are considered preventable, no concluding evidence exists that current devices are effective in the prevention of PU´s. In fact, 38.5% of PUs appeared while using any of these preventive devices. The inefficacy of actual devices is a consequence of:
- Focusing only on the reduction and relief of pressures, instead of controlling and improving tissue viability
- Most of current systems do not provide a control variable (feedback), enabling to adapt real-time to the tissue status of each zone, and the few devices that do have a control variable assesses mainly pressure
- Actuation strategies are applied without taking into account the users needs and contextual situation
- Integration and optimal combine of different actuation devices, since some are only suitable for certain target groups and zones, taking advantage of the most optimal combination of these devices

PUMA project aims to develop a novel portable and non-invasive system to prevent and early detect the risk of PU development and revert its onset at T-SCI individuals relying on wheelchairs, based on the control and improvement of tissue viability. Therefore, a combination of tilt-inclining system, a dynamic cushion and Functional Electrical Stimulation (FES) will be optimally integrated, preserving tissue viability as well as increasing the resistance to PU development. The trigger of these strategies will be based on smart textile, which will measure tissue viability and pressure on the buttocks. This will substantially increase the time that T-SCI sufferers can spend sitting, their independent living and social inclusion while reducing health risks.

Therefore, the aim of PUMA project has been to develop a PU prevention and early detection system for T-SCI sufferers in wheelchairs that would not only rely on relieving pressures, but also on real-time tissue viability control of the patient taking into account user and context characteristics. After assessing PU risk, PUMA will warn the user and activate an optimal combination of dynamic actuation devices (as are the tilt-in-space wheelchair and dynamic pressure cushion) to restore tissue viability. Moreover, PUMA will increase the resistance to develop PUs by improving the muscular and vasomotor status through Functional Electrical Stimulation (FES). Puma system will thus compensate the sensory and mobility loss of T-SCI as well as improve muscular tone and baseline vasomotor condition, preventing PU development by controlling and improving tissue viability.

Project Results:
During PUMA project execution we have reached the following results:

- R1: Smart Short, embedding the different tissue viability sensors and FES electrodes in an electronic-textile short and a cushion case with the pressure sensors.
- R2: Dynamic actuation system composed of the integration of tilt-in-space wheelchair and dynamic pressure cushion.
- R3: FES Control for adjusting the parameters for muscular and vascular stimulation based on measured tissue viability for T-SCI.
- R4: Risk Measurement Control,being the brain of the system receiving the measurement data from the smart short and cushion case, assessing the risk of developing a PU.
- R5: Actuation Control for managing the repositioning movements of the dynamic actuation system and dynamic cushion according to the PU development risk assessment.
- R6: PUMA System is the global product, which is composed of the integration of R1 to R5.

The PUMA solution, as well the different combinations to prevent PU (see D8.3, D8.4). will be exploited into the Assistive Technology Market. Moreover, each result will be also exploited in other markets such as e-Textile for sports or healthy or rehabilitation and fitness market.

Making the analysis WP by WP

1. WP1. Characterisation of T-SCI persons and healthy patterns
In WP1 we have gained the required knowledge about PU development process in T-SCI sufferers and their general needs. We have identified the mechanisms that prevent healthy users from developing PUs. The results of this WP has been key inputs to define the system requirements (WP2). IBV has performed, supported by each of the partners in its expertise field, several tests with healthy users and T-SCI sufferers.

The main objectives covered in this WP have been:
1. The selection of the optimal sensors
2. The determination of the safety thresholds of buttock tissue of T-SCI sufferers
3. The characterization of the baseline status of buttock tissue of T-SCI sufferers
4. The characterization of the needs of T-SCI persons in their daily life and contexts of use
5. The determination of the FES patterns for PUMA purposes

2. WP2. Requiremens of PUMA system
Once we had obtained the needs of the users it was required to translate them into design requirements for the different subsystem and the overall PUMA system. This has been the main aim of this WP to translate gathered T-SCI needs and characteristics into requirements for each component and for the overall PUMA system.

WP2 has defined the functional, technical, accessibility, usability, comfort and aesthetic requirements to ensure two main elements. On one side, to make much more easier to go for a CE marking at the end of the project, as a medical device. On the other side, to enhance the satisfaction of user-system interaction.

WP2 has involved all RTD partners focusing on their expertise fields: IBV on biomechanics and repositioning movements, CTB on smart textiles and EII on control systems. The SME has supported the definition of the component requirements: QIM for repositioning systems, ST for textiles and BB for FES.

The main objectives covered in this WP have been:
1. To gather requirements and test related with medical standards
2. To define technical, functional, usability and aesthetics requirements on FES, sensors, textiles, dynamic cushion, tilt, intelligent control system and alarm and user interface.
3. To develop conceptual design of PUMA system for its assessment with T-SCI persons.

3. WP3. Development of a smart textile
WP3 has focused on the development of the smart pants, one of the sub-systems of PUMA. These smart pants have covered two functions: (i) a sensing function to detect the tissue viability and environmental status (humidity, temperature); (ii) to allocate correctly the Functional Electrical Estimulation (FES) electrodes. In this WP we have developed also the pressure sensors, finally integrated into the cushion.

The main objectives covered in this WP have been:
1. To development the textile based sensors
2. To development the textile based electrodes enabling FES
3. To develop the smart shorts using previous developed textiles and adjusting the number and distribution of electrodes. Two critical aspects of this development have been to ensure a good electrode contact with the skin to ensure the comfort of the user, and to to ensure the washability of the system.

4. WP4. Development of wheelchair components
In WP4 we have developed and adapted the wheelchair components: dynamic pressure cushion, tilt-in-space system and user interface taking into account the indications defined in WP2. Table 1 (see annex) shows the main components of the system. IBV has provided their knowledge on biomechanics, assistive devices and user-centred design, supported by QIM for the requirements and limitations, of the current solutions, and by EII for ensuring its control /WP5) and interaction (WP6).

The main objectives covered in this WP have been:
1. The development of a dynamic cushion with 3 independent zones distributed according to zone risk (e.g. ischios).
2. The development of a tilt-in-space system with a reduced range and with a fine adjusted angle sets steps using.
3. The development of the user interface to notify risk to T-SCI sufferers and allow to –cancel/modify each strategy suggested by the control of the system accordind the the risk data recorded.

5. WP5. Development of control system
Under WP5 we have developed all the work required for the development of the SW-HW modules.

The main objectives achieved in this WP have been:
1. The development of the processing algorithms for sensors signals to cancel artifacts and noise and to extract the key parameters needed as input for the decision making system, with will be the basis of the intelligent control system.
2. The development of the decision making algorithms to tigger strategies depending on the PU risk, user and context characteristics
3. The development of the intelligent control system to optimize FES and repositioning (by means of the dynamic cushion and tilt-in-space system) strategies and trigger alarms based on the decision making algorithms output.
4. The development of the electronics required to obtain/record the key data and transform it into the activation of actuators and electrodes according to the overall defined strategies and algorithms.

6. WP6. Integration and technical testing
This has been one of the most critical WPs as all needed to work properly ensembled together. That has been the main aim of this WP, to integrate all components of PUMA system (WP3, WP4 and WP5) following indications of WP2 and test technical performance and safety before starting test with healthy users and T-SCI patients WP7.

WP6 has covered the following objectives:
1. The PUMA system has been tested according to relevant related standards and own developed procedures to ensure safety of users (before testing the system with them) and to make easier to get the CE marking in the next steps of going to the market
2. To integrate wheelchair components and its control in the wheelchair
3. To integrate the smart shorts and its control in the wheelchair

7. WP7. Validation
The objective of WP7 has been to validate the PUMA system along each phase of design and development to ensure fitting to T-SCI needs. Healthy users and T-SCI persons have participated in these tests complementing the technical tests without users. A first step, in this WP was the definition by IBV of the inclusion criteria, protocol and success metrics of each test.

It is worth mention the importance of the active involvement of the users in the achievements of this project. The participation of the users at the project has been presented to the AAATE (Association for the Advancement of Assistive Technology in Europe) 2015 Conference to take place in September 1015. Users have been involved in the different WPs of the project. As the most relevant involvement has taken place in the validation WP, Table 2 (see attached Annex) presents a summary of the participation of users and stakeholders.

Figure 1 (see attached annex) shows some examples of the different involvement user process and key inputs to achieve the final design of the solution. It should be highlighted the high level of usability and acceptance of SCI users and professionals, which is reinforced by the quantitative measures that have assess the effectiveness of PUMA system to detect PU risk and reduce it by combining three strategies: wheelchair movement, dynamic cushion and electrical stimulation.

One of the critical points have been the validation in real environment of use. The final assessment of the users and the professionals were quite satisfactory. They identified some concern about the robustness of the system, somehow expected because the condition of a prototype. But, in global terms, the PUMA solution acceptance was high, the stakeholders identified key benefits of the system, and user satisfaction, usability an performance was considered good.
Next figure shows the satisfaction of patients and professionals with the effectiveness of different strategies proposed by the system, being 5 the maximum (see figure 2 of attached annex).

Moreover, the level of acceptance and purchase is intention is also high (being 5 the maximum), with needs of improves on aesthetics as it is common in any prototype (see figure 3 of attached annex)).

8. WP8. Dissemination and exploitation
The objective of this WP, led by the Exploitation manager from Qimova, has been to facilitate and encourage the industrial and commercial exploitation of the results and define the measures to ensure that the SME consortium members will be able to assimilate, protect, exploit and disseminate the results of the project. The modularity and scalability of the system will help to the companies involved in the project to exploit the results. In addition, at this moment the consortium has initiated the process to patent the system, parallel to the contacts with and investment fund group to go next steps to put the product into the market.

The business and market plan is defined in D8.3 and D8.4 but due to IPR issues, details can not be provided. It should be highlighted the patent process of PUMA solution.

In relation to dissemination, all activities are described in D8.1 and more information in the Section 4.2 of this document):

9. WP9. Management and coordination
The main objective of this WP has been the effective coordination and management of knowledge, IPR, Consortium Agreement (CA), financial, legal and contractual coordination of the work at consortium level and coordinate information and management between the EC and consortium.

During the project the consortium applied for an extension in order to be able to perform additional activities to facilitate CE marking of the product and to incorporate additional improvements identified during the different validation processes.

- NEXT STEPS

The main challenge is to define and implement an effective “go to market strategy”. To do so, Qimova has initiated the patentability of the results and is working with an investment fund group to move forward in the development of the PUMA system. From a more technical point of view the following point will need to be addressed:

• To increase robustness and reliability of components and subsystems for industrial production.
• To test long term benefits of FES to increase muscular strength.
• To achieve CE medical mark.
• To feed algorithms with long term tests during 1 year clinical validation for fine tuning.

Potential Impact:
A large number of dissemination activities has taken place mainly related to promote the awareness about the needs of T-SCI users and other profiles of user who could benefit of the features integrated into the PUMA system.

The dissemination, however, has been made in overall concepts to ensure the patentability of the system. At this moment the consortium has initiated the patent process, one of the requirements of the investment fund group.

The main dissemination activities have been:

- 79 items were released in mass media including websites, newsletters, TV, radio and press. 11 of them were published in Specific magazines, websites and other journals linked to PUMA objectives. Mainly the media approached are based on Spain. According to the type of media, 60 were released in websites, 7 in newsletter, 1 in TV, 1 in radio, 8 in press and 1 in specialized magazines. This result is considerably above of the indicator “Impacts in mass media >20”.

- QIM has attended to one Fair/trade (see figure 4) and it is planned to attend to 4 more fairs during next year to show the current version of PUMA prototype (waiting to close patent request). This result will reach the indicator “ Trades and Fairs > 2”.

- 11 papers has been published on journals/technical magazines. This result is considerably above of the indicator “Papers published on other journals/technical magazines > 4”.

- 3 contributions to journals/conference has been done. Moreover, we are waiting for the acceptance of two more papers and to send two scientific articles when patent request was finished. This result is above of the indicator “Papers published on indexed Scientific-Technical Journals and Conferences >2”.

In September, during the AAATE Conference IBV will present two related papers with the participation of the users in this project.

Two other papers related to FES are already written but are waiting for the patent release.

- Two draft of scientific papers (waiting to start patent):
– Comparative of methodologies to measure tissue status and blood flow
– Effectiveness of PUMA strategies by measuring pressure and blood flow measures (result of previous paper).

Finally, a promotional video has been developed and can be downloaded using the following link (first article of section news):
http://puma.ibv.org/index.php/dissemination/news

List of Websites:
Project public website address: http://puma.ibv.org/

Related information

Contact

Henrik Grauslund, (Director)
Tel.: +45 21294631
E-mail
Record Number: 182667 / Last updated on: 2016-05-11
Information source: SESAM