Buyers guide

Functional electrical stimulation for

drop foot of central neurological origin
CEP10010
February 2010

Contents 2
CEP10010: February 2010
Introduction ............................................................................................. 3
Technical considerations ......................................................................... 8
Operational considerations .................................................................... 13
Economic considerations ...................................................................... 24
Purchasing ............................................................................................ 26
Acknowledgements ............................................................................... 28
Glossary ................................................................................................ 30
References............................................................................................ 32
Appendix 1: EU procurement procedure ............................................... 36
Appendix 2: Literature review methods ................................................. 39
Author and report information ................................................................ 43

Introduction 3
CEP10010: February 2010
CEP buyers guides are intended to provide prospective purchasers of healthcare
products on the UK market with general guidance on the technical, operational, and
economic considerations to be taken into account in selecting the most appropriate
product where a range of similar products exists. They do not include product-
specific information, which is published separately via market reviews (which contain
product specifications only) or evaluation reports (which contain additional technical
and / or user evaluation data). Readers are encouraged to check CEPs web site for
updates.
Scope
This buyers guide is restricted to the application of functional electrical stimulation
(FES) for drop foot of central neurological origin, although other potential uses of
FES are discussed briefly. The guide summarises the clinical evidence, and the
operational, technical and economic considerations which impact on purchasing
decisions and the provision of FES services in the UK.
It should be noted that individual FES systems will not necessarily offer all of the
capabilities mentioned in this guide. Device-specific information is provided in CEPs
associated market review [1].
Background
Functional electrical stimulation (FES) is the application of electrical stimulation to
nerves in order to produce muscle contractions. It is used to treat the effects of upper
motor neurone lesions resulting from conditions such as stroke, cerebral palsy,
multiple sclerosis or spinal cord injury. The stimulation may be from electrodes on the
skin surface, or from implanted electrodes placed directly around the nerves.
FES is not normally suitable for patients with lower motor neurone lesions, such as
polio or motor neurone disease.
Drop foot is the inability to lift the foot and toes during walking. Central neurological
origin means that the drop foot is due to damage to the central nervous system, such
as might arise from stroke, cerebral palsy, multiple sclerosis, spinal cord injury, or
other less well known conditions such as familial spastic paraparesis. [2].
During normal walking, the legs alternately move forwards (swing phase) or stand
supporting the body (stance phase). There is a brief overlap of stance phases where
both legs are supporting the body (figure 1). During each step, the heel leaves the
ground first, followed by the rest of the foot. The leg then swings forward with a bent
knee and flexed foot. At the end of the step the knee is straightened and the heel
Introduction 4
CEP10010: February 2010
touches the ground (heel strike). The rest of the foot is then gradually lowered to the
ground and the leg and body come forwards until they are above the foot.
Figure 1. Typical gait cycle showing heel rise and heel strike

Drop foot means that the foot does not flex sufficiently during walking, and the toe
tends to drag on the floor. The resulting difficulties in walking, such as slowness,
tripping and tiredness [3-5], lead to a reduction in mobility and independence. NICE
[6] states that the ability to negotiate the environment independently is fundamental
to all aspects of daily life and almost all aspects of social participation are dependent
upon adequate mobility. Limitation in mobility is one of the prime determinants of the
amount (time and number of people) of care needs, whether given by family or paid
carers.
Current treatment options for drop foot, other than FES, are primarily physiotherapy
and the use of an ankle-foot orthosis (AFO). An AFO is a passive device that is worn
on the lower leg and foot to improve gait and control the motion of the foot. There are
many different designs of AFO available, with varying amounts of flexibility. AFOs will
support the foot and ankle, but will not activate the users own muscles to enhance
walking. Additionally medical therapy (such as baclofen and botuxulin) or surgery
may sometimes be used.
FES can be used for many purposes. It is used as both a physiotherapy tool during
sessions to exercise muscle and improve function, and as a rehabilitation aide to be
used in daily activities. Its use is not confined to drop foot, FES may be used on
many areas of the upper and lower limbs. Examples include improving stability when
standing, reducing hand spasticity and improving hand function.
Introduction 5
CEP10010: February 2010
FES has been provided in the UK for fifteen years [7] and its use for drop foot has
been known for longer [8]. Despite this its use is not very widespread and many
people cannot access FES without travelling large distances, or are unaware of the
service, or cannot obtain funding. There are many potential users that could benefit
from increased levels of service provision in a greater number of locations.
How FES works
FES requires that there are functional nerves in the limb (peripheral nerves), since it
is the nerve that is stimulated. To stimulate the muscle directly would require a much
higher current. The nerve stimulation then causes muscle contraction, in the same
way as for a normally functioning limb. The nerve may either be stimulated through
the skin by a surface electrode, or directly by an implanted electrode.
The stimulation intensity required will vary depending on the electrical resistance
between the electrode and the nerve, amongst other factors. This varies with the type
of electrode used and the tissue through which the stimulus passes. Skin has high
resistance and must be clean and have good contact with the electrode. Gel is
normally used and may be an integral part of the electrode. Fat also has a high
resistance and larger patients will require higher intensity of stimulation, as will
patients with oedema (fluid retention causing swelling in limbs) where there is a lot of
tissue between the electrodes and the nerves. Implanted electrodes use a much
lower intensity since they are in direct contact with the nerves to be stimulated.
A sensor detects a trigger event in the walking pattern, such as the heel leaving the
ground (heel rise). This starts stimulation of the nerves and results in muscle
contractions. Stimulation is stopped by a second trigger event, such as the return of
the heel to the ground at the end of the step (heel strike).
The clinician is able to customise the stimulation to suit the user. The user can
control some basic functions such as stimulation intensity. The intensity of stimulation
required may vary throughout the day (eg due to tiredness).
National guidance
NICE published guidance on FES in 2009 [9], indicating that the procedure is
sufficiently safe and effective to be routinely offered as a treatment option provided
that the patient understands what is involved and agrees to the treatment, and the
results of the procedure are monitored.
Where electrodes are to be implanted a healthcare team including rehabilitation
specialists should be involved in deciding which patients should have the procedure
[2].
Introduction 6
CEP10010: February 2010
In 2005 NICE guidance on the management of multiple sclerosis [6] emphasised the
importance of mobility and independence, stating that Physiotherapy treatments
aimed at improving walking should be offered to a person with MS who is, or could
be, walking.
The government's National Stroke Strategy [10] states that Long-term assistance,
review and rehabilitation are essential if people are to lead autonomous lives and
overcome physical, psychological and attitudinal barriers and to engage and
participate in community activities. It mentions FES as a new technology with which
service providers need to keep pace.
The National Service Framework (NSF) for long term conditions [11] includes a
quality requirement, QR7: People with long term neurological conditions are to
receive timely, appropriate assistive technology/equipment and adaptations to
accommodation to support them to live independently, help them with their care,
maintain their health and improve their quality of life.
The Multiple Sclerosis Society has published guidance [12] for patients on how to
access FES treatment. It explains what FES is, summarises the evidence for its use,
and includes several case studies.
All medical devices should be CE marked, and British standard BS EN 60601-2-
10:2001 Part 2.10: Particular requirements for the safety of nerve and muscle
stimulators [13] sets out standards for FES devices.
Introduction 7
CEP10010: February 2010
Literature review
We reviewed published literature, using the methods described in appendix 2, to
identify significant studies published since the NICE evidence review [9]. Particular
consideration was given to the following technical factors:
comparison of implanted with surface electrodes
comparison of heel switches with alternatives such as accelerometers or tilt
sensors
comparison of wired with wireless systems
the importance of flexibility in electrode positioning.
We found no studies that directly addressed these concerns. There were several
papers that gave background information and these are referenced as appropriate.
We found no major study results published since the NICE evidence review [9].
However, there was one literature review [14].
There is no conclusive evidence on the relative performance of different FES
systems, and many of the decisions to be made in choosing equipment are likely to
be based largely on user preference and clinical judgement.
Technical considerations 8
CEP10010: February 2010
FES devices consist of the following components:
stimulating unit - providing a pulsed electrical signal
clinician control enabling the device parameters to be set for the user
user control normally controlling the intensity and on/off switch
sensor - to detect gait events
electrodes the point at which the signal is applied to the patient.
These components may all be contained within one physical unit, or in several
separate devices. For separate components, communication may be wireless or
wired.
Stimulation parameters
Waveform
FES provides stimulation, in the form of a rapidly pulsed electrical current, for the
duration of the swing phase in the affected leg. The waveform used in FES
stimulators is normally charge
balanced, meaning that there is no
net flow of current between
electrodes. The pulses may be
symmetrical or asymmetrical
(figure 2) and this may be fixed
by the manufacturer or variable
by the clinician. Asymmetrical
waveforms are more commonly
used [15]. They produce a
stronger stimulation and the
positions of the active and neutral
electrodes can be interchanged
to alter muscle responses. Some
users report that symmetrical
waveforms minimise skin
reaction and are more
comfortable[16].
Asymmetrical biphasic waveform, a strong positive
pulse followed by a weaker negative pulse.
Symmetrical biphasic waveform, every other
pulse is reversed to give symmetry.
Figure 2. Typical FES waveforms [16]
Technical considerations 9
CEP10010: February 2010
Amplitude, frequency and pulse width
These three parameters (figure 3) can be used to vary the muscle contraction
strength. Contraction strength will also be dependent on many other factors such as
limb size, oedema and placement of electrodes.
Pulse width is the length of time that the pulses last. Interpulse interval is the time
from the start of one pulse, to the start of the next, and the inverse of frequency
(1/frequency). Amplitude is the strength or magnitude of the current applied in the
pulse. All stimulators allow the user to adjust the stimulation level. In some cases it is
the pulse width that is adjusted, in others the amplitude. The increase in stimulation
experienced is similar by either method.
The frequency of the current is also important. If it is too low then the muscle twitches
visibly, if it is very high the muscle fatigues rapidly. A frequency of around 40 Hz (40
pulses per second) is usually used to give a sustained contraction without tiring the
user too quickly. It can usually be adjusted by the clinician if required.
Ramp up, ramp down and extension
Ramp up and ramp down are the gradual rise or fall of stimulation intensity (figure 4).
Extension is the continuation of the stimulation after heel strike. The duration of these
parameters is normally determined by the clinician during set up. Alternatively the
extension duration may be fixed as a percentage of the stride time, as measured by
the stimulator. Where a percentage is used the extension times will be shorter when
gait is faster.
a
m
p
l
i
t
u
d
e

pulse width
interpulse
interval
time
s
t
i
m
u
l
a
t
i
o
n

Figure 3. diagram to illustrate pulse width, amplitude and interpulse interval
Technical considerations 10
CEP10010: February 2010
Some ramping is desirable for comfortable stimulation. Shorter ramp times (up and
down) will suit faster walkers. Longer ramp up times may be useful to reduce calf
stretch reflexes and avoid muscle spasms that can be triggered by rapid stretching.
Extension is used to gently lower the foot to the floor at the end of the step. This
avoids foot slap, where the foot rapidly falls down to the ground after heel strike.
Stability may also be improved at the end of the step by using extension and ramp
down

Changes in stimulation level
Most devices follow the pattern shown in figure 4. Some devices allow programming
for stimulation level to be increased or decreased at different points in the stride.
Delay
Delay is the time from the trigger to the start of stimulation. For a standard drop foot
set-up this would be zero. Where alternative muscle groups are stimulated, a delay
may be required.
Max time
This is the maximum time that stimulation will continue. It is also known as the time
out period. If the end trigger is not sensed, stimulation will stop after a set duration.
An option to allow stimulation to continue indefinitely can also be useful, for instance
if stimulation is to be used for muscles used for standing.
Figure 4. diagram to illustrate typical FES stimulation pattern
Heel
rise
Heel
strike
Ramp
down
S
t
i
m
u
l
a
t
i
o
n

Time
Ramp
up
Extension
Main stimulation time
Technical considerations 11
CEP10010: February 2010
Wait time
This is the time that must elapse after one stimulus ends and before the next
commences. . It is intended to ensure that there is sufficient time allowed for each
step to be completed by preventing unintentional stimulation during stance.
Sensors
Sensors commonly used include on/off foot switches, force sensing resistors, and tilt
sensors or accelerometers. The type used is largely dependent on the trigger
chosen.
Foot switches and force sensing resistors are commonly used on the heel and detect
the heel rise and heel strike. They are normally placed under an inner sole in the
shoe and require that a shoe is worn. A foot switch will normally start stimulation
when pressure is removed, and stop stimulation when pressure is replaced. It does
not measure the amount of pressure applied.
A force sensing resistor measures the pressure applied. This enables the stimulator
to calculate further information about the users gait. Calculations may include
adjustments to the pressure required for triggering when walking on softer ground, or
differentiating between inadvertent foot strikes and genuine steps.
Tilt sensors are normally a form of accelerometer. They measure tilt, or angular
displacement, using the action of gravity on the sensor. The method varies with the
sensor design used. Sensors are typically placed on the leg, and may be contained
in a single device [17]
Tilt sensors require some processing of the data by the stimulator device, in order to
recognise the correct part of gait in which to activate stimulation. This may involve
collecting data while the user is walking and using software to analyse this and set a
trigger threshold.
There are no clinical trials comparing the effectiveness of different sorts of sensors,
although several papers describe the use of each [7,17].
Some papers describe tilt sensors placed on the trunk [18] and also complex
systems of tilt sensors on various parts of the leg [19-21]. Research has been done
using both sensory nerve signals and muscle activation, or electromyography (EMG),
to detect trigger events [22,23]. At present this is not used in any stimulators
available in the UK.
Technical considerations 12
CEP10010: February 2010
Power
All FES devices require battery power. There is a choice between disposable or
reusable standard batteries or a custom rechargeable power pack. Reusable
batteries will not last as long as a disposable battery before they need recharging.
However, rechargeable batteries for all stimulators currently on the market allow at
least 12 hours use (allowing overnight charging) and may not need charging for
several weeks.
Operational considerations 13
CEP10010: February 2010
To treat drop foot the peroneal nerve is
normally stimulated. The standard positions
for surface electrodes are on the lower leg
(figure 5). Placement is adjusted to give the
required movement of the foot.
The main considerations are summarised in
table1.
Triggering
Triggering is how the system recognises
that it is the right time in the gait cycle to
apply stimulation. This is normally a choice
between heel rise/strike and the angle of the
leg. The choice is dependent on the users
gait characteristics and preferences that
affect the choice of FES system.
Heel rise and heel strike on the affected foot
can be used where there is good contact between the heel and ground during
stance, and where the heel is the first part of the foot to leave the ground, and the
first to return to the ground. This is the case during normal gait, but may not be the
case in all FES users. This is a commonly used triggering method [24]. Triggering
may also be from the non-stimulated limb, if this foot has a more readily detected
heel rise and strike. In this case stimulation starts on heel strike, after some delay.
Tilt sensors, to detect the angle of the lower leg, can be used when there is sufficient
flexion of the leg during gait. Where the leg remains very straight during walking the
triggering may be ineffective. One advantage of tilt sensors is that they do not require
a component in the shoe. This means that the stimulator may be used without shoes,
and eliminates the need for wires or other means of communication between the foot
and the stimulator.
The trigger methods available depend on the FES system selected.
Ease of use
This is very important since many users may also have restricted upper limb mobility.
Many users who have had strokes will need to set up the equipment with only one
hand. They may also be elderly with reduced dexterity and poor eyesight. If setting
up the device is too difficult then people may cease to use it {Taylor 79 /id;Taylor,
1999 156 /id}.
Figure 5. Peroneal nerve and electrode
positions for drop foot FES
Operational considerations 14
CEP10010: February 2010
Table 1. Summary of main operational considerations
Communication Wires Wireless Single location
low cost easy to set up simple to set up
fiddly to set up no visible wires may limit other options.
trailing wires visible. remote units must be
powered.

Sensor Tilt on leg Foot switch Force sensor on foot
no shoes needed shoes required shoes required
need sufficient leg flexion simple, low cost enables variable trigger
activation threshold
sensor included in device separate sensor required. separate sensor required
walking trials and data
analysis to set trigger.
device must calculate trigger
activation threshold.
Electrode
positioning
Implant Cuff By user
permanent positioning electrode position fixed on
cuff
user must be trained
surgery required. cuff must be correctly
orientated on leg
relies on user skill
may be bulky for some
trousers etc
flexible placement, allowing
clinician to utilise alternative
electrode positions, or
stimulate other muscle
groups.
cuff pressure may improve
electrode contact.

Clinician
features
Clinician unit Stimulator unit (analogue) Stimulator unit (digital)
additional unit required adjust parameters directly scroll through menus to set
up
store user data. can seem complicated when
unfamiliar
data stored on patient unit.
Recorded in notes by
clinician.. no recording of data.
Operational considerations 15
CEP10010: February 2010
Electrode positioning
Correct electrode positioning is critical to get the desired foot movement. There are
three approaches:
implant the electrodes, placement is then permanent and fixed
place the electrodes on a cuff that fits around the calf. The electrodes are fixed on
the cuff and then if the cuff can be replaced in the same position on the leg then
electrode position will be correct. Cuff positioning can be made simpler by
shaping it, for instance with a curved section that fits around the patella (knee
cap). The chosen electrode positions must fit within the cuff, meaning that
alternative stimulation sites cannot be used. Good contact between skin and
electrode is important, and it is possible that use of the cuff improves this contact.
train the user to place the electrode in the correct position. This is reinforced
during the frequent check up appointments (common when first using FES), by
photos, diagrams and marking the electrode position on the leg during the initial
fitting. This method allows clinicians to use alternative electrode positions, and
also to stimulate different muscle groups.
All of these methods have been used successfully and the choice will often depend
on the preferences, or needs, of the user as well as the other characteristics of the
chosen system.
Location
The user control and stimulation units may be placed on the leg, on a waistband or in
a pocket. Where the device contains a tilt sensor it is normally placed on the leg.
Placement on a waistband or pocket allows the user to adjust the intensity and switch
the unit on or off whilst standing, but requires additional units and either wires or
wireless technology for communication.
Where the controls and stimulation unit are on the leg the user must sit down to
adjust the controls. This removes the need for communication between units since
they may be housed in the same device. The device may be bulky for wearing under
some clothes.
Operational considerations 16
CEP10010: February 2010
Communication between system components
There are three approaches commonly used:
wired connections, requiring the user to connect wires at each use. Wires are
visible if shorts or skirts are worn
wireless communications, requiring power for all communicating units
integration of all components, avoiding the need for remote communication.
Controls
These should be clearly visible and easy to operate with reduced dexterity. Controls
may be push buttons with light emitting diode (LED) displays or dials with printed
values.
Unintentional activation
When sitting or standing, accidental triggering of the device is undesirable. This can
be avoided by the user putting the device on pause, or by the device recognising the
difference between an intended step and an inadvertent footstrike. After pausing, the
units should retain the previous settings.
Standby and sleep modes
These modes are designed to save energy and avoid unintentional stimulation. If the
unit is not used for some time, it may go into standby, and this may be followed with
a sleep mode or switching off. The user needs to be aware how the unit reactivates
and if the intensity settings will remain the same, or reset to initial levels. In the
morning, or when rested, users may require lower settings.
Battery changes
Users must be able to recharge or change batteries as needed. Clinicians or
technicians may be required for some additional infrequent battery changes.
Implanted or surface electrodes
The vast majority of FES users in the UK at present use surface electrodes.
Implanted electrode systems require surgery, have a relatively high cost and are
normally only recommended for people with an established use of FES. They have
advantages for users who cannot tolerate surface electrodes because of skin
sensitivity or who have difficulty in correctly placing electrodes. They may also be
Operational considerations 17
CEP10010: February 2010
desirable for long term, frequent users of FES due to minimising the amount of
equipment and set up time..
Flexibility
Drop foot is one of the most common uses of FES and the starting point for many
new services. However there are many other potential uses of FES and this should
be considered when starting a service and purchasing equipment.
Consumables
Surface electrodes need replacing regularly. Other items such as foot switches may
also need replacing occasionally. The price and expected life of these must be
included in the equipment cost. Some devices require that electrodes are purchased
from the device manufacturer.
Clinician training
Clinician skill, experience and knowledge are very important factors in FES being
effective for the user. Training at present is only offered by device suppliers. The
available training should be part of the purchase decision. This may include the
training in FES or may be restricted to how to use the product, assuming staff have
an understanding of FES techniques. Training may also be required for new
members of staff at a later date, or to update or refresh current staff.
Where implanted electrodes are used it is essential that surgeons are appropriately
trained in implanting the device. Manufacturers recommendations for training should
be followed and the cost of this training (including surgical staff hours) should be
included when considering the device.
Maintenance
The only routine maintenance required is generally basic cleaning, charging and
replacing batteries and replacing consumable items. This can be completed by the
user.
Users may depend on the device for mobility so there should be some means of
replacing a faulty device during repair or ensuring that repair is rapid.
Purchase decisions should take into account the support available if a device is
faulty, including the charges, time taken for repairs, and the availability of
replacement devices.
Operational considerations 18
CEP10010: February 2010
Exercise mode
This allows the user to exercise muscles while seated. This may increase muscle
strength, range of movement and tolerance of the stimulation sensation. It may also
reduce oedema, spasticity and pain. The exercise mode might be used to enable
someone to start using FES for functional movement, to increase the length of time
they use FES, or to alleviate other symptoms.
The FES device applies a regular on/off cycle of stimulation for a set amount of time.
The stimulation parameters may be adjustable to different levels during exercise than
for walking.
Clinician features
Clinicians need to be able to adjust the device parameters to suit the user. They may
also want to record these parameters and monitor the amount of use that is made of
the device over time.
Parameter adjustment may be made directly on the main stimulation unit or via an
additional clinician unit such as a PC or a dedicated personal digital assistant (PDA).
Where a clinician unit is used there is the possibility to store user data centrally,
uploading stimulator parameters to the patient device and downloading usage data. If
programming is on the main stimulation unit these data will have to be manually
recorded from the unit if a record is required. However, no additional clinician unit
need be purchased.
Setting up a FES service
Small FES services are starting up in many locations. Patients are treated on an
individual basis and reports are sent to local health boards to request funding. As the
number of patients increases, a fully funded FES service may become a more cost-
effective option.
In order to set up a FES service, a valid business case should be produced. The
business case outlines the reasons for the new service, considers the options
compared with existing arrangements, describes the expected benefits, costs and
timescales for implementation, and how the changes in service will be evaluated.
Calculating patient numbers
It is important to predict the number of patients that will be using the new service.
Patients with neurological conditions such as stroke, spinal cord injury, cerebral palsy
and MS among others, can be considered appropriate candidates. FES can be used
Operational considerations 19
CEP10010: February 2010
to stimulate the nerves on upper and lower limbs, improving limb function, circulation
and mobility and so is also suitable for a number of disabilities other than drop foot.
The number of expected patients can be estimated by different methods. Existing
services have either used:
the number of referrals previously received per month in addition to the
number of patients currently treated to estimate the number of future patients
population catchment areas to determine potential patient numbers, although
this typically gives a higher number of patients than would actually be seen.
(One estimate is that approximately 0.1-0.2% of the total UK population may
benefit from FES [27].)
Patients deemed suitable for FES typically require treatment until there is either a
deterioration of their condition (eg MS), or an improvement of their condition (eg
stroke) so that they no longer require FES.
Clinical pathway
A typical clinical pathway for a patient who has been referred for FES using surface
electrodes is shown in figure 6. The pathway may vary considerably between clinics
and for different devices. The patient attends an initial assessment to see if a FES
device is suitable. This would usually last one hour. If suitable, the patient attends a
clinic to have the device fitted at a subsequent appointment. The fitting appointment
can last up to an hour and a half. After their initial fitting, patients will be required to
return to the clinic within a short period of time, typically the next day, to assess if
they have managed to fit the electrodes correctly and can use the device confidently.
If the assessor is satisfied that the patient is able to correctly fit the electrodes, they
are then seen at 3 months, 6 months, and then annually until the patient ceases
treatment. Telephone support is sometimes available, and some assessments can
be made over the phone if the patient is in a remote location. Appointments after the
fitting appointment usually last one hour. Telephone support can be important in
addition to appointments, allowing problems to be identified and addressed rapidly.
The clinical pathway for systems using implanted electrodes would be different from
that shown in figure 6, although typically the patient would have been fitted with a
surface electrode system prior to consideration for implanted electrodes

Operational considerations 20
CEP10010: February 2010

Staff
FES clinics are usually staffed by physiotherapists, clinical scientists, or both, with
administrative support for patient appointments and ordering of equipment. A patient
would typically need to be seen for six and a half hours of appointment time in the
first year of treatment, and if there are no problems, one hour in subsequent years.
The number of staff required to service the clinic would depend on the number of
patients. One full time clinician would typically manage 130
2
patients in a year.
1
Fitting and follow up appointments may be longer if more than one channel is being set up
2
In a survey of 10 FES services for this report, the number of patients seen by one whole time
equivalent clinician ranges from 116 to 223, with a median of 130.
Initial assessment
appointment
1 hour
Fitting appointment
1.5 hour
1

Suitable?
No
Yes
Finish
Fitting appointment
follow up
1 hour
Long term follow up*
appointment
1 hour
Within 2 days
Continue?
No
Finish
Yes
* At 6 weeks,
3 months,
6 months then
every 12 months
Figure 6. Typical clinical pathway for FES patients
Operational considerations 21
CEP10010: February 2010
Training
Staff should receive training from each of the manufacturers whose devices they will
be fitting. If there are any new devices or upgrades of existing devices then further
training should be sought. In addition to training, experience is important in achieving
a good stimulation result. Ideally staff should be setting up devices and training
patients in their use on a regular basis. Staff who do not fit devices on a regular basis
should receive a refresher course.
Accommodation
Ideally, a large room is used that would fit a 10m walkway with space at each end
and each side. This would allow cameras to be set up with sufficient field of view to
record the patients gait from the front and from the side. It is also advisable to allow
some extra length before the walkway for gait to stabilise before measurements. A
well lit room with blackout blinds on the windows will ensure consistent lighting levels
for video recording and patient privacy. The walking area should be clearly marked
with enough room for patients to use walking aids unhindered.
Recording a patient using a video camera is not essential in setting up a FES service
but can be a valuable tool in assessing a patients gait and progress. There should
also be space for a desk, computers, equipment and stationary storage and an
examination area with seating for the patients and clinicians. A small waiting area for
patients is also needed.
Equipment
A basic FES clinic can be run with very little equipment. The FES devices should be
available at the clinic for the patient to try during assessment. Some clinics stock
additional devices ready to give to patients immediately whilst other clinics order
devices as required. Most clinics have a supply of consumables such as electrodes,
footswitches and footswitch leads.
In addition to the devices and consumables, the equipment required to run a clinic
would ideally include: a video camera to record a patients gait, a digital camera to
record the position of the electrodes on the patients leg, a stop watch and heart rate
monitor to record outcome measures, a computer for the administration of patient
appointments and a separate computer for the clinician to record patient data at each
appointment with software to analyse the video footage of the patients gait.
Operational considerations 22
CEP10010: February 2010
Measuring treatment outcome
Current FES service providers stated that they measured patient benefits using:
video footage of the patient walking, filmed simultaneously from the front, rear,
and side. Patients are filmed before and after the FES device has been fitted
and at all of their follow up appointments. Walking speed and improvement in
gait are assessed
walking speed, calculated by timing the patient over a known distance using a
stopwatch
physiological cost index (PCI) to measure the effort of walking before and after
treatment. PCI is calculated from the patients heart rate during a walk over a
set distance
clinical examinations before and after the device has been fitted, including
assessments of muscle strength, spasticity and range of movement to record
any improvements
goal attainment scores, set by the patient and the clinician and assessed at
each appointment
questionnaires designed to assess changes in quality of life.
Staff questionnaires may also be of value in assessing the performance of a FES
service and determining how it might be improved.
Operational considerations 23
CEP10010: February 2010
Guidance on calculating FES service costs
Table 2 outlines the main costs of setting up a FES service. There may be other local
costs which have not been identified here.
Table 2 Guidance on calculating FES service costs

Capital costs
Clinician equipment FES device programmer (if applicable)
Walking aids
Couch, goniometer, stopwatch
Video camera and /or digital camera
Blackout blinds
Assessment equipment Range of FES devices for fitting to
patient
Training Each member of staff requires training
prior to fitting FES devices

Operating costs
Accommodation Rent
Utilities Electricity, gas, water
Consumables Heel switches, electrodes, leads,
batteries, stationary
Clinician staff
(physiotherapist and / or
clinical scientist)
Allow a minimum of five and a half
hours clinic time per patient in their first
year and one hour in subsequent years
Training New members of staff will requires the
initial training for any devices they will fit
Administration staff Management of FES service, day to
day running of clinic, patient notes
Economic considerations 24
CEP10010: February 2010

Published evidence on cost-effectiveness
Following a systematic search of recognised electronic databases in November 2009
we found a single cost utility study using 1996 data [28]. This study looked at the
Odstock Dropped Foot Stimulator (ODFS), an external device with surface
stimulators as used for drop foot following stroke. Results suggested that there was a
0.065 QALY gain with FES versus 0.023 with physiotherapy, at a cost per QALY of
10,037 with five years continuous use. These calculations were based on a cost of
166 per use (including the cost of building and maintaining the stimulator and the
supply of consumables) and a mean cost per year of 431.60 for use over five
years).
New economic model
A new model for estimating the cost effectiveness of the ODFS when used for stroke
patients using 2009 cost data was developed. The cost-utility model takes a payer
perspective (NHS) and reports outcomes as cost per quality adjusted life years
(QALYs). Costs and outcomes were not discounted. Both a one year and a five year
time horizon were used for the model. Full details are given in the CEP economic
report [29].
Cost inputs to the model
Costs are based on an assessment appointment costing 140, and on a clinic model
in which the cost of the FES device are incorporated in the ongoing clinic charges.
Each ongoing clinic appointment has been estimated at 300. The model includes an
assumption that patients all have five clinic visits in the first year, and between one
and two in the second and subsequent years. In the base case it is assumed that
50% of patients have two clinic visits in each ongoing year, and 50% will have one
clinic visit each year. Other charging arrangements can be used in the model to test
how different cost structures affect incremental cost-effectiveness.
Other inputs to the model
Utility is estimated from studies reporting quality of life measures associated with
functional improvements after stroke. Walking speed is the outcome measure from
the effectiveness literature used to derive utility. The model was limited by the
availability of suitable data, There may be other aspects of quality of life that are
improved by the ODFS for which there is no research data. More research is needed
in this area.
Economic considerations 25
CEP10010: February 2010
Summary of results
The conservative base case suggests that FES has cost per QALY in the region of
19,238. In this model the cost per QALY in the first year is in the region of 52,337
and in each subsequent year in the region of 10,964.
Sensitivity analysis undertaken on the static model demonstrated that the model was
sensitive to changes in time horizon, and assumptions regarding any gain in health
utility. Costs for alternative stimulators can be input into an interactive version of the
model to test the effects of varying these inputs on the incremental cost effectiveness
ratios.
Discussion
Conservative modelling of functional electrical stimulation using the ODFS for drop
foot due to stroke shows that it is likely to be cost effective compared to no treatment.
There is significant potential to organise services to optimise that cost-effectiveness.
Selected patients should be able to commit to long term treatment

Purchasing 26
CEP10010: February 2010
Purchasing procedures
The Trust Operational Purchasing Procedures Manual provides details of the
procurement process [30].
European Union procurement rules apply to public bodies, including the NHS, for all
contracts worth more than 90,319 (from January 1
st
2008) [31] (appendix 2). The
purpose of these rules is to open up the public procurement market and ensure the
free movement of goods and services within the EU. In the majority of cases, a
competition is required and decisions should be based on best value.
NHS Supply Chain (www.supplychain.nhs.uk), a ten year contract operated by DHL
on behalf of the NHS Business Services Authority, offers OJEU compliant national
contracts or framework agreements for a range of products, goods and services. Use
of these agreements is not compulsory and NHS organisations may opt to follow
local procedures.
Sustainable procurement
The UK Government launched its current strategy for sustainable development,
Securing the Future [32] in March 2005. The strategy describes four priorities in
progressing sustainable development:
sustainable production and consumption working towards achieving more with
less
natural resource protection and environmental enhancement protecting the
natural resources and habitats upon which we depend
sustainable communities creating places where people want to live and work,
now and in the future
climate change and energy confronting a significant global threat.

The strategy highlights the key role of public procurement in delivering sustainability.
Production and packaging
FES devices are generally made from all new materials. Most elements of an FES
device are designed to be used for several years, minimising the impact of
production and packaging. More complex devices require more components and
hence increased production, packaging and transport impact would be expected.
Reconditioning
FES devices may state that they may not be used for more than one patient.
Purchasing 27
CEP10010: February 2010
Some items such as stimulator units and control units may be reconditioned and
reused for several patients, if allowed by the manufacturer. Some simpler devices
may also be appropriate for reuse in developing health economies. The ability to
directly adjust the device and reducing the number of peripheral items will assist this.
Consumables and cuffs are single-patient use.
Use
Power consumption is low for all devices, and this may be further reduced where
there is the option of standby or sleep modes. Devices with wireless communication,
or additional units for programming require power for the accessory units, increasing
the overall power consumption. Use of reusable batteries, where allowed by the
device manufacturer, will minimise the impact of the power supply.
All batteries must be disposed of in accordance to the Batteries Directive that came
into force in September 2008 [33]. Disposable batteries cannot be sent to landfill.
Most users will need to take batteries to a local recycling centre. Using rechargeable
batteries minimises the number of waste batteries.
End-of-life disposal
Consideration should be given to the likely financial and environmental costs of
disposal at the end of the products life. Where appropriate, suppliers of equipment
placed on the market after the 13
th
August 2005 should be able to demonstrate
compliance with the UK Waste Electrical and Electronic Equipment (WEEE)
regulations (2006) [34].

The WEEE regulations place responsibility for financing the
cost of collection and disposal on the producer. Electrical and electronic equipment is
exempt from the WEEE regulations where it is deemed to be contaminated at the
point at which the equipment is scheduled for disposal by the final user. However, if it
is subsequently decontaminated such that it no longer poses an infection risk, it is
again covered by the WEEE regulations, and there may be potential to dispose of the
unit through the normal WEEE recovery channels.

Acknowledgements 28
CEP10010: February 2010
We should like to thank the following for their contribution to this buyers guide.
Alison Clarke, Clinical Specialist Physiotherapist, Movement Analysis and Research,
Sheffield Teaching Hospitals NHS Foundation Trust
Phillip Casson, Managing Director, Odstock Medical Limited
Karen Edwards, Administration Manager, Orthotic Research and Locomotor
Assessment Unit (ORLAU), The Robert Jones & Agnes Hunt Orthopaedic & District
Hospital NHS Trust
David Ewins, Consultant clinical scientist, Douglas Bader Rehabilitation Centre,
Wandsworth Primary Care Trust
Salim Ghoussayni, Business Development Manager for neurostimulation, Ottobock
Healthcare PLC
Jon Graham, Clinical Director, Physiofunction
Adele Griffiths, Clinical Lead for Neurophysiotherapy, Aneurin Bevan Health Board
Steve Hunt, Orthotics Service Manager, Dacey Ltd
Carol McFadden, Director, FES North West Limited
Lisa Matter, Country Manager UK, Bioness
Media Resources, School of Medicine, Cardiff University
Linda Miller, Consultant Physiotherapist in Multiple Sclerosis, NHS Ayershire & Arran
Paul O Connell, Principal Clinical Scientist & Rehabilitation Engineer, Cardiff and
Vale University Local Health Board
Sue Paddison, Superintendent/Clinical Specialist Physiotherapist, Spinal Cord Injury
Centre, Royal National Orthopaedic Hospital Trust
Faye Pitt, Senior Orthotist, Trulife Limited
Acknowledgements 29
CEP10010: February 2010
Neil Postans, Bioengineer, Orthotic Research and Locomotor Assessment Unit
(ORLAU), The Robert Jones & Agnes Hunt Orthopaedic & District Hospital NHS
Trust
Christine Singleton, Lead Clinician for Rehabilitation and Clinical Specialist (FES),
West Midlands Rehabilitation Centre, South Birmingham Primary Care Trust.
Paul Taylor, Consultant Clinical Engineer, Head of FES Research, National Clinical
FES Centre, Salisbury Hospital NHS Foundation Trust
Wendy Watson, Specialist Neurological Physiotherapist and Director, Neurocare
Physiotherapy Ltd
Duncan Wood, Consultant Clinical Scientist, National Clinical FES Centre, Salisbury
Hospital NHS Foundation Trust

Glossary 30
CEP10010: February 2010

accelerometer A device that measures acceleration. This may be due to
gravity or movement.
AFO Ankle foot orthosis, a device, usually made of plastic,
which is worn on the lower part of the leg and on the foot. It
is used to align the lower leg correctly and control the
motion of the ankle and foot, to provide stability and
improve gait [5].
amplitude The amount of current applied.
charge balanced No net flow of electrical current across the patient.
Discounting
The process used in cost analyses to mathematically
reduce future costs and/or benefits/outcomes to their
present value. These adjustments reflect that given
levels of costs and benefits occurring in the future
usually have less value in the present than the same
levels of costs and benefits realised in the present.
electrode Device used to apply electric current to nerves, either
directly or through the skin.
extension Continuation of stimulation for some time after the trigger
to end stimulation.
frequency Number of pulses per second, measured in Hertz (Hz)
gait Manner or style of walking
heel rise The moment that the heel leaves the ground at the start
of the swing phase.
heel strike The moment that the heel touches the ground at the end
of the swing phase.
oedema Fluid retention that causes swelling in limbs
pulse rate See frequency
pulse width Time that a pulse lasts. This is not the total time that
stimulation lasts in the gait cycle.
quality adjusted life
year (QALY)
A unit of health care outcomes that adjusts gains (or
losses) in years of life subsequent to a health care
intervention by the quality of life during those years.
QALYs can provide a common unit for comparing cost-
utility across different interventions and health problems.
ramp down Gradual decrease of intensity level at the start of
stimulation.
Glossary 31
CEP10010: February 2010
ramp up Gradual increase of intensity level at the start of
stimulation.
tilt sensor This is normally an accelerometer used to give
information on the inclination of the sensor from vertical.
trigger The signal that starts or stops stimulation
trigger threshold The value of the signal that is needed for the trigger to
function.
utility The relative desirability or preference (usually from the
perspective of a patient) for a specific health outcome or
level of health status.
References 32
CEP10010: February 2010

(1) Centre for Evidence-based Purchasing. Market review: Functional electrical
stimulation for drop foot of central neurological origing. NHS Purchasing and
Supply Agency. 2010. CEP10011.London.
(2) National Institute for Health and Clinical Excellence. Information about NICE
interventional procedure guidance 278. 2009.
(3) Burridge JH, Haugland M, Larsen B, Pickering RM, Svaneborg N, Iversen HK, et
al. Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in
established hemiplegia. Journal of Rehabilitation Medicine . 2007. 39 (3):212 -8
(4) Burridge J , Taylor P , Hagan S , Wood D , Swain I. The effect of common
peroneal nerve stimulation on quadriceps spasticity in hemiplegia. Physiotherapy
(PHYSIOTHERAPY), 1997; 83(2): 82-9
(5) National Institute for Health and Clinical Excellence. Interventional procedures
overview 278: Functional electrical stimulation for drop foot of central neurological
origin. 2009.
(6) National Institute for Health and Clinical Excellence. Clinical guideline 8: Multiple
Sclerosis; National clinical guideline for diagnosis and management in primary
and secondary care. 2004.
(7) P N Taylor, J H Burridge, A L Dunkerley, D E Wood, J A Norton, C Singleton, et
al. Clinical use of the odstock dropped foot stimulator: Its effect on the speed and
effort of walking. Archives of Physical Medicine and Rehabilitaion 1999;80:1577-
83
(8) Liberson WT, Holmquest DS, Dow M. Functional electrotherapy, stimulation of the
peroneal nerve synchronized with the swing phase of the gait of hemiplegic
patients. Archives of Physical Medicine and Rehabilitaion 1961;42:101-5
(9) National Institute for Health and Clinical Excellence. Interventional procedure
guidance 278: Functional electrical stimulation for drop foot of central neurological
origin. 2009
(10) Department of Health. National Stroke Strategy. 2007.
(11) Department of Health. National Service Framework for long term conditions.
2005.
(12) Multiple Sclerosis Society. How to campaign for access to FES. 2009.
Available online at:
http://www.mssociety.org.uk/get_involved/policy_campaigns/campaigns_network/
campaigning_guides/access_fes_guide.html
last accessed: 22/09/2009
(13) British Standard. BS EN 60601-2-10:2001 Medical electrical equipment-Part
2.10: Particular requirements for the safety of nerve and muscle stimulators.
(2001).
References 33
CEP10010: February 2010
(14) IJzerman MJ, Renzenbrink GJ, Geurts ACH. Neuromuscular stimulation after
stroke: from technology to clincial deployment. Expert Review 2009;9(4)
(15) Robinson AJ, Snyder-Macker L. Clinical Electrophysiology. Williams & Wilkins;
1994.
(16) National FES Centre. PACE update training presentation. 2009.
(17) Stein RB, Chong S, Everaert DG, Rolf R, Thompson AK, Whittaker M, et al. A
multicenter trial of a footdrop stimulator controlled by a tilt sensor.
Neurorehabilitation & Neural Repair 2006. 20 (3):371 -9 ,
(18) Mansfield A, Lyons GM. The use of accelerometry to detect heel contact events
for use as a sensor in FES assisted walking. Medical Engineering & Physics
2003. 25 (10):879 -85
(19) Veltink PH, Franken HM. Detection of knee unlock during stance by
accelerometry. [Review] [21 refs]. IEEE Transactions on Rehabilitation
Engineering 1996. 4(4):395 -402
(20) Williamson R, Andrews BJ. Detecting absolute human knee angle and angular
velocity using accelerometers and rate gyroscopes. Medical & Biological
Engineering & Computing 2001. 39 (3):294 -302
(21) Williamson R, Andrews BJ. Sensor systems for lower limb functional electrical
stimulation (FES) control. Medical Engineering & Physics 2000. 22 (5):313 -25
(22) Upshaw BJ, Sinkjaer T. Natural versus artificial sensors applied in peroneal
nerve stimulation. Artificial Organs 1997. 21(3):227 -31
(23) Dutta A, Kobetic R, Triolo RJ. Gait initiation with electromyographically triggered
electrical stimulation in people with partial paralysis. Journal of Biomechanical
Engineering 2009. 131 (8 )
(24) Stein RB, Rolf R, Everaert DG, Bobert J, Chong S. Surface Electrical Stimulation
for Foot Drop: Control aspects and walking performance. Journal of Automatic
Control 2008;18(2):47-52
(25) Taylor P, Burridge J, Dunkerley A, Wood D, Norton J, Singleton C, et al. Clinical
audit of 5 years provision of the Odstock dropped foot stimulator. Artificial Organs
1999. 23(5):440 -2
(26) Taylor PN, Burridge JH, Dunkerley AL, Lamb A, Wood DE, Norton JA, et al.
Patients' perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clinical
Rehabilitation. 1999:13: 439-446
(27) Personal communication with National FES Centre, Salisbury. (2009).
(28) Swain I, Taylor P, Burridge J, Hagan SA, Wood D. Report to the Development
Evaluation Committee: Common peroneal stimulation for the correction of drop-
foot., South and West Regional Development and Evaluation Committee.
Available online at:
References 34
CEP10010: February 2010
http://www.salisburyfes.com/dec.htm.
Last accessed: 22/09/2009
(29) Centre for Evidence-based Purchasing. Economic Report: Functional electrical
stimulation for drop foot of central neurological origin. NHS Purchasing and
Supply Agency. 2010.London.
(30) NHS Purchasing and Supply Agency. Guidance - NHS trust operational
purchasing procedures manual - TOPPM. 2009. London. Available online at:
http://nww.pasa.nhs.uk/PASAWeb/Guidance/TOPPM/LandingPage.htm
Last accessed: 22/09/2009
(31) Office of Government Commerce. Policy and standards framework - EU
procurement thresholds applicable from 1 January 2008. 2008. London. Available
online at:
http://www.ogc.gov.uk/procurement_policy_and_application_of_eu_rules_eu_pro
curement_thresholds_.asp
Last accessed: 22/09/2009
(32) Department for Environment Food and Rural Affairs. UK Government Strategy
for Sustainable Development - Securing the Future. 2008. London. Available
online at:
http://www.defra.gov.uk/sustainable/government/publications/index.htm
Last accessed: 22/09/2009
(33) The stationary office limited. The Batteries and Accumulators (Placing on the
Market) Regulations 2008. . Available online at:
http://www.opsi.gov.uk/si/si2008/pdf/uksi_20082164_en.pdf
Last accessed: 22/09/2009
(34) Her Majesty's Staionary Office. Statutory instrument 2006 number 3289 - The
Waste Electrical and Electronic Equipment Regulations 2006.. London. Available
online at:
http://www.berr.gov.uk/files/file35992.pdf
Last accessed: 22/09/2009
(35) NHS Purchasing and Supply Agency. National framework for operating leases
(extended until 31 March 2010). 2009. Available online at:
http://www.pasa.nhs.uk/PASAWeb/Productsandservices/Leasing/Nationalframew
orkforoperatingleases/
Last accessed: 22/09/2009
(36) Office of Government Commerce. Business change template - business case.
2009. Available online at:
http://www.ogc.gov.uk/documentation_and_templates_business_case.asp
Last accessed: 22/09/2009
(37) NHS Purchasing and Supply Agency. OPPM - Operational purchasing
procedures manual. 2009. Available online at:
References 35
CEP10010: February 2010
http://nww.pasa.nhs.uk/PASAWeb/Guidance/OPPM/LandingPage.htm
Last accessed: 22/09/2009
(38) Department of Health. Procurement publication - European Union tendering
timetable. 2004. London. Available online at:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsProcur
ement/DH_4070620
Last accessed: 22/09/2009
(39) Department of Health. Procurement publication - Desk guide to procurement -
2005 edition. 2005. London. Available online at:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsProcur
ement/DH_4109316
Last accessed: 22/09/2009
(40) National Institute for Health and Clinical Excellence. Clinical Guideline CG65:
The management of inadvertent perioperative hypothermia in adults. 2008.
Available online at:
http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11962
Last accessed: 22/09/2009
(41) Centre for Evidence-based Medicine at the University of Oxford. Evidence-
based medicine tools - asking focussed questions. 2009. Available online at:
http://www.cebm.net/index.aspx?o=1036
Last accessed: 22/09/2009

Appendix 1: EU procurement procedure 36
CEP10010: February 2010
Lease options
National frameworks are in place for operating leases to help the NHS procure
leases more cost efficiently and effectively. Further details are available from the
PASA website [35].
EU procedures
The Public Sector Directive (2004/18/EC) has been transposed into UK law via the
following statutory instruments:
the Public Contracts Regulations SI 2006 No.5 (the regulations)
the Utilities Contracts Regulations SI 2006 No. 6 (not relevant to this guide).
The regulations apply to contracts worth more than 90,319 (from January 1
st
2008)
[31] over their whole life, and specify the procedures to be followed for public sector
contracting, including adherence to strict timetables, requirements for advertising,
invitation to tender and the award of contract. Organisations undertaking a
procurement exercise covered by the regulations must give all suppliers an equal
opportunity to express an interest in tendering for the contract by placing a contract
notice in the Official Journal of the European Union (OJEU).
At all stages of the procurement process, the purchaser must be demonstrably fair,
as any decision made can be challenged by the unsuccessful suppliers.
Establishing a procurement strategy
To achieve a successful outcome, decisions need to be made on:
whether an existing contract/agreement can be used
the need to consider sustainable development issues
whether EU directives apply
the type and form of contract
sourcing potential suppliers
duration of contract and opportunity to review/extend
payment schedules
how to minimise any risks with the chosen strategy, including supplier appraisal
and evaluation/clarification of suppliers bids.


Appendix 1: EU procurement procedure 37
CEP10010: February 2010
Preparing a business case
A business case should be drafted and approved before conducting any procurement
exercise. Further guidance on preparing business cases is available from the Office
of Government Commerce [36] and an illustrative example is provided in the NHS
PASA Operational Purchasing Procedures Manual, Procedure 1-01 [37].
The EU tendering exercise
EU procurements usually take between 4 and 6 months to complete. This needs to
be taken into account in the planning stages. The length of the exercise depends on
the chosen procedure (open or restricted). Further information is available from the
Department of Health [38].
The procurement panel
A multidisciplinary team should be selected to guide the purchase. Representatives
from clinical, user, technical, estates and financial areas should be considered.
Identifying potential suppliers
Criteria for supplier selection must be established. A pre-qualification questionnaire,
seeking background information (eg on the skills and experience of the service
engineers) may be employed as an initial screen to exclude unsuitable suppliers.
Evaluation criteria
Performance specifications should be derived from local operational requirements,
and agreed by the procurement panel. They will form the basis for assessing the
adequacy of suppliers technical specifications, provided in response to the technical
specification questionnaire.
It is important to have agreed on the performance specifications of the product as
they will be used in the adjudication against company specifications.
Requests for features which are supplier-specific are not permitted under the
regulations. Very specific features which are not supported by operational
requirements are also not allowed.
Award of contract
Following award of the contract to the successful supplier; unsuccessful suppliers
may need to be debriefed. This is at the suppliers request.
Appendix 1: EU procurement procedure 38
CEP10010: February 2010
Buyers must be aware of the Alcatel procedure (see the Trust Operational
Purchasing Procedures Manual [30], Procedure No.T-08, section 6 - Mandatory
Standstill Period).
For more information on procurement please refer to the Department of Health
Website [39].

Appendix 2: Literature review methods 39
CEP10010: February 2010
Introduction
The recent NICE interventional procedure guidance Functional electrical stimulation
for drop foot of central neurological origin undertook a comprehensive systematic
literature review to consider the efficacy and safety of FES in this context. The search
strategy for NICE was used as the basis for the search strategy
Research question
A research question was defined according to the population, intervention,
comparison, outcome (PICO) structure, described by the University of Oxfords
Centre for Evidence-based Medicine [41] as shown in the table 3 below.
Table 3. Research question
Population Intervention Comparison Outcomes
Patients with
drop foot of
central
neurological
origin
Functional
electrical
stimulation
(implanted or
surface
electrodes)
1. tilt sensors
vs foot
sensors
2. wires vs
wireless
technology
3. implanted
vs surface
electrodes
4. standard
drop foot
electrode
position vs
other
positions
Clinical studies:
walking speed
quality of life measures
Physiological cost index
(PCI)
Patient satisfaction
Complications
Continued use of device
Gait analysis

Simulation studies
Technical studies

Appendix 2: Literature review methods 40
CEP10010: February 2010
Literature search strategy
The section below shows the search strategies that were run on the MEDLINE
database (1950-present)
Implanted vs surface electrodes:

1 exp electric stimulation therapy/ (30702)
2 exp electric stimulation/ (109176)
3 ((function$ or neuromuscul$ or peripheral$ or transcutan$ or electric$) adj3
stimulat$).tw. (57685)
4 (FES or TENS or NMES or FNS).tw. (7520)
5 or/1-4 (168985)
6 gait/ (12793)
7 exp gait disorders, neurologic/ (2260)
8 gait$.tw. (17545)
9 (foot adj3 drop$).tw. (635)
10 (foot adj3 spastic$).tw. (130)
11 or/6-10 (24021)
12 exp electrodes/ (61242)
13 (electrode$ adj3 (implant$ or external$ or internal$)).tw. (6513)
14 or/12-13 (64971)
15 5 and 11 and 14 (151)
16 Animals/ (4526199)
17 Humans/ (11087380)
18 16 not (16 and 17) (3377684)
19 15 not 18 (135)

tilt vs foot switch:

1 11 as above
12 ((foot$ or heel$) adj3 (sensor$ or switch$ or trig$)).tw. (283)
13 (tilt$ adj3 (sensor$ or switch$ or trig$)).tw. (47)
14 or/12-13 (328)
15 Animals/ (4526199)
16 Humans/ (11087380)
17 15 not (15 and 16) (3377684)
18 (accel$ or gyro$).mp. [mp=title, original title, abstract, name of substance word,
subject heading word, unique identifier] (119587)
19 14 or 18 (119884)
20 5 and 11 and 19 (54)
21 20 not 17 (49)

Appendix 2: Literature review methods 41
CEP10010: February 2010
Electrode position

1 11 as above
12 5 and 11 (868)
13 exp electrodes/ or exp electrodes, implanted/ (61242)
14 electrode$.mp. (85096)
15 (placement or position or location or site).mp. [mp=title, original title, abstract,
name of substance word, subject heading word, unique identifier] (866247)
16 13 or 14 (104277)
17 15 and 16 (11950)
18 Animals/ (4526199)
19 Humans/ (11087380)
20 18 not (18 and 19) (3377684)
21 12 and 17 (37)
22 21 not 20 (34)

wire vs wireless

1-11 as
12 5 and 11 (617)
13 Animals/ (1909528)
14 Humans/ (5178019)
15 13 not (13 and 14) (1268056)
16 exp Telemetry/ (3003)
17 (wireless$ or radio$ or telemetr$).mp. [mp=title, original title, abstract, name of
substance word, subject heading word, unique identifier] (367717)
18 16 or 17 (367717)
19 6 and 12 and 18 (6)
20 19 not 15 (6)

In addition, searches were run on Web of Science, CINAHL, EMBASE, and Medline
In-Process. A request was also made for stakeholder organisations to identify
unpublished studies. These methods identified 212 studies that might be of interest.

Study eligibility criteria
Studies that compared FES devices, or aspects of FES devices could be included.
These were restricted to English language and human subjects.
16 papers were identified for further scrutiny. The studies were summarised in a
standard format and any relevant studies were assessed for quality..
Appendix 2: Literature review methods 42
CEP10010: February 2010
Results
Although there are many case studies, and some trials that look at FES, these tend
to look at the efficacy of FES treatment, using one particular FES device. There were
no studies found that directly compared FES devices, or aspects of FES devices.
Conclusions drawn from the evidence
There is an inadequate volume of high quality evidence comparing different FES
devices. There is no study that compares any of the devices currently marketed in
the UK.
Author and report information 43
CEP10010: February 2010
Buyers guide:
Functional electrical
stimulation for drop foot of
central neurological origin

Megan Dale, Joelle Williams, Grace
Carolan-Rees, Rachel Taft *, Alan
Lovell *, Rob Cook *


Clinical Engineering Device
Assessment and Reporting (CEDAR)
Cardiff Medicentre
Cardiff
CF14 4UJ

Tel: 029 2068 2120
Email:cedar@.wales.nhs.uk
www.cedar.wales.nhs.uk

* Bazian Ltd
10 Fitzroy Square
London
W1T 5HP

Tel: 020 7874 1594
Email: info@bazian.com
www.bazian.com


About CEP
The Centre for Evidence-based
Purchasing (CEP) is part of the Policy
and Innovation Directorate of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support
the uptake of useful, safe and
innovative products and related
procedures in health and social care.
We are here to help you make
informed purchasing decisions by
gathering evidence globally to support
the use of innovative technologies,
assess value and cost effectiveness of
products, and develop nationally
agreed protocols.
Sign up to our email alert
service
All our publications since 2002 are
available in full colour to download
from our website. To sign up to our
email alert service and receive new
publications straight to your mailbox
contact:
Centre for Evidence-based Purchasing
Room 152C
Skipton House
80 London Road
SE1 6HL

Tel: 020 7972 6080
Fax: 020 7975 5795
Email: cep@pasa.nhs.uk
www.pasa.nhs.uk/cep

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