THE VIENNA FES SYSTEM FOR RESTORATION OF WALKING FUNCTIONS IN
SPASTIC PARAPLEGIA

M. Bijak W. Mayr, M. Rakos**, C. Hofer*, H. Lanmüller, D. Rafolt, M. Reichel, S. Sauermann,
C. Schmutterer, E. Unger, M. Russold, H. Kern*

Department of Biomedical Engineering and Physics, University of Vienna, Austria

*Department of Physical Medicine and Rehabilitation, Wilhelminenspital, Vienna, Austria

**Otto Bock, Austria

SUMMARY

 

An eight-channel stimulation system, currently intended for stimulation of lower extremities was developed and is introduced. Major development goals were easy handling, modularity to make the system easy adaptable for other FES applications and a wide stimulation parameter range for application specific parameter optimisation.

For paraplegic stepping the system worn by the patient consists of two four channel stimulation modules, a central unit holding the battery and circuitry for power management and communication control, a wireless remote control unit and a palmtop computer as main control and input device.

A software package for MS-Windows supports the design and optimisation of stimulation sequences in the rehabilitation centre.

First tests with patients used to FES showed smoother movements during stepping and acceptable good handling. In combination with the PC software the required stimulation sequences could be created in a very short time.

 

STATE OF THE ART

 

Stimulation of leg muscles in spastic paraplegia to restore standing up from the wheelchair, stepping and sitting down into the wheelchair is a well-known FES application /1/. Muscle activation with implanted stimulators via nerve and motor point attached electrodes /2,3,4/ or with external stimulators via surface electrodes /5/ are state of the art.

Surface stimulation needs careful system setup before usage, has a limit in the amount of useful channels and a worse muscle selectivity in comparison to implanted systems but does not require any surgical intervention.

 

 

MATERIAL AND METHODS

 

Text Box:  Fig. 1: Block diagram of the eight channel stimulation systemThe introduced stimulation system (Fig. 1) consists of two four-channel stimulators (one for each leg), a control device (Central unit) and a Windows CE based palmtop computer. An additional battery powered Command Unit can be mounted on a crutch or a walker for manual wireless stimulator control by pressing push buttons.

A special software package, installed on a standard PC or Laptop computer supports stimulation pattern design and interactive testing.

 

Stimulation module:

The stimulation module houses four independent stimulation stages (channels). Each channel is controlled by its own microprocessor (PIC 16F876, Microchip, Chandler, AZ, USA) and can deliver any stimulation sequence that can be defined by moving the corner points of the burst envelope shown in Fig. 2. Stimulation frequency and pulse duration of the positive and negative part of the biphasic rectangular impulses can be set individually for each greyed region.

The micro controller drives the impulse generating output stage. Text Box:  

Fig. 2: Envelop of a stimulation burst
For safety reasons and to keep the electrodes potential free an output transformer is used.

Electrode impedance measurement and m-wave acquisition are implemented even though the m-wave is currently not evaluated.

All channels are linked together and are controlled via Inter-Integrated Circuit bus (I2C bus).

The chosen microprocessor is flashable and allows in circuit firmware update.

 

Central unit:

Text Box:  

Fig. 3: Block diagram of the Central Unit
The central unit holds the batteries, power supply and battery charging circuitry, bus management circuitry, the RS232 / I2C translation unit and the 433 MHz receiver (RX2-433, Radiometrix Ltd, Hertfordshire, England) for the Command Unit.

Two RS232 ports are available to connect a Palmtop Computer and a PC. During the initialisation phase the Bus Manger can be programmed to connect the PC to the RS232 / I2C Interface or palmtop computer to the RS232 / I2C Interface giving them access to the stimulation devices or to connect PC and palmtop for direct data transfer via RS232.

Beside this the Bus Manager is also responsible for the decoding of the control signals sent by the command unit (standard RS232 protocol, 9600 baud). The state of the Command Unit can be polled either from the Palmtop or the PC. Further more the Bus Manger can be configured (via I2C) to trigger autonomously the stimulation devices on Command Units request. Therefore multimaster management had to be implemented in both, I2C interface and Bus Manger.

 

Command Unit

The Command Unit is based on a commercially available 433MHz FM transmitter (TX2-433, Radiometrix Ltd, Hertfordshire, England) and a microprocessor (16F876) with integrated A/D converter. The state of up to four pushbuttons and the value of up to 4 analog signals are continuously scanned, encoded and sent. To get a data transfer rate of 9600 Baud a coding strategy is necessary that keeps the digital signal DC free. This is simply done by consecutive sending one byte and the inverted byte, a technique also useable for data validation.

The described data transmission procedure results in a sample rate of the pushbuttons of 250/s, in 250/s for one analog channel and 62.5/s each for four analog channels.


After an idle time of 10 minutes the command unit enters sleep mode to reduce power consumption. Wakeup is performed when any button is pressed.

The radio link can be bypassed by a cable connection in the case when more Command Units are operating in a close distance and interfere with each other.

 

Palmtop Computer

 

Text Box:  
Fig. 4: Screenshot from the Palmtop Computer software
A MS-Windows CE based device with touch screen (Ipaq 3130, Compaq, Houston, Texas, USA) is used as portable main control unit. The advantage is that the operating system takes over all the interface handling, offers convenient methods for database access and synchronisation between Plamtop and PC and also network access.

As development environment MS Embedded Visual C++ is used. ADOCE, also a MS product, supports data exchange with MS Access databases while ActiveSync provides all drivers for automatic database synchronisation.

The graphical user interface is designed as simple as possible. The often used buttons are sized to be easily activated with the fingertip. After turning on the device, the patient can choose a stimulation sequence from the database for standing up, walking and sitting down. In the next step each single channel can be tested with the possibility to adapt the stimulation amplitude within a 20% range. Finally the stimulation is activated and the Palmtop can be stowed away. Then the control is handed over to the Command Unit.

When the stimulation is running the screen shown in Fig. 4 offers the opportunity to adjust the stimulation amplitude of all channels at once, again in a 20% range.

Changes of the device’s state like switching from standing up to walking are confirmed by either playing a wav-file or activating the beeper. Obviously the sound volume can be adjusted or switched off.

A wireless LAN connection to the PC, also supported by the operating system and ActiveSync, can be used for data exchange but requires additional hardware (a PCMCIA wireless LAN card and a PC card jacket) to be mounted on the Palmtop Computer.

 

PC Software Package

The software package for Laptop Computer or PC is designed to devise and optimise stimulation sequences.

Different visual and non-visual software components were created with Delphi (Borland, Scotts Valley, CA, USA) and provide the basic functions like communication with the hardware, graphical stimulation pattern editing and data handling. These components can be easily integrated in any user specific Delphi application or can be converted to ActiveX components and then implemented in most other MS- Windows development environments. After compiling the source code with Kylix (Borland) Linux applications are also supported. For a more detailed description please refer to the poster presentation of M. Russold at this conference.

In this particular case the described components are used to build a comfortable Graphical User Interface (GUI) to ease the patient individual stimulation parameter optimisation. During the testing phase the PC controls the stimulators via cable connection directly or with the wireless LAN connection via the Palmtop Computer.

After the stimulation pattern works satisfying the patient related data is extracted from the underlying MS-Access database and transferred to the Palmtop Computer for patients personal use.

 


RESULTS

 

The strictly kept modular concept (in hardware as well as in software design) allowed to break down the whole functionality to specific tasks and to distribute them to eleven microprocessors that cooperate among each other and with one PC and one Palmtop Computer reliably.

First tests showed that the whole system is easy to use although some software improvements are still ongoing.

The previous version had nearly the same features like the described system, but was more bulky and was not intended to be used outside the clinic or rehabilitation centre. Two T6 patients, familiar with FES supported stepping with a six channel surface stimulator, used the prototype and participated in first trials. Both patients agreed with the therapists that smoother and better coordinated movements could be achieved by exploiting the available parameter range during the optimisation phase /5/.

The prototype was also successfully adapted for a project where paraplegic patients rode a newly constructed tricycle by means of FES /6,7/.

 

DISCUSSION

 

The introduced eight-channel stimulation system for lower extremities is now subject to an industrial transfer project with Otto Bock Austria. After first testing clinical trials will start soon.

 

REFERENCES

 

/1/ Strojnik P, Kralj A, Ursic I: Programmed six-channel electrical stimulator for complex stimulation of leg muscles during walking. IEEE Trans Biomed Eng 1979;26:112-116

/2/ Davis R, Houdayer T, Andrews B, Emmons S, Patrick J: Paraplegia: prolonged closed-loop standing with implanted nucleus FES- 22 stimulator and Andrews' foot-ankle orthosis. Stereotact Funct Neurosurg 1997;69:281-287.

/3/ Holle J, Frey M, Gruber H, Kern H, Stöhr H, Thoma H: Functional Electrostimulation of Paraplegics; Experimental Investigations and First Clinical Experience with an Implantable Stimulation Device. Orthopedics 1984;7:1145-1155.

/4/ Kobetic R, Triolo R J, Uhlir J P, Bieri C, Wibowo M, Polando G, Marsolais E B, Davis J A Jr, Ferguson K A: Implanted functional electrical stimulation system for mobility in paraplegia: a follow-up case report. IEEE Trans Rehabil Eng 1999;7:390-398.

/5/ Bijak M, Hofer C, Lanmuller H, Mayr W, Sauermann S, Unger E, Kern H:  Personal computer supported eight channel surface stimulator for paraplegic walking:first results. Artif Org 1999;23:424-427

/6/ Angeli T, Gföhler M, Eberharter T, and Rinder L: Tricycle for paraplegics using functional electrostimulation. Med&Biol. Eng&Comput 1999, 37:326-327.

/7/ Bijak M, Reichel M, Hofer C, Gföhler M, Mayr W, Eberharter T, Angeli T, Lugner P, Rinder L, Kern H: Tricycle for Paraplegic’s: Stimulation Equipment. 3rd Int. Conference on Bioelectromagnetism Proceedings (ISBN 961-6210-95-5), 2000, 217-218

 

ACKNOWLEDGEMENTS

 

This project is supported by Otto Bock Austria.

 

AUTHOR’S ADDRESS

 


Manfred BIJAK, PH.D.

Department of Biomed. Eng. an Physics

Waehringer Guertel 18-20/4L

1090 Vienna, Austria


Tel.: +43-1-40400/1992 (1983)

Fax.: +43-1-40400/3988

E-Mail: m.bijak@bmtp.akh-wien.ac.at