The effectiveness of the Ness L-300 neuroprosthesis compared to the use of a conventional AFO or orthopaedic shoes (OSA) on
walking activity of stroke patients

Many stroke patients have a spastic drop foot. These patients experience
difficulty when walking because they are unable to effectively dorsiflex their
ankle during the swing phase of walking.This lack of swing leg flexion
predominantly causes stroke patients to experience difficulties while walking,
due to insufficient foot clearance. The common treatment for drop foot is the
prescription of an ankle-foot orthosis (AFO) or orthopaedic shoes. Most AFOs
take away passive ankle motion in the frontal plane, while they limit plantar
flexion at the ankle or provide an external dorsiflexion moment. Hence the
major disadvantage of an AFO is the absence of normal ankle kinematics during
gait, thereby reducing active ankle stability and related balance reactions.
Devices using functional electric stimulation (FES) have been introduced as an
alternative treatment method for drop foot. The NESS L300® is a recently
developed peroneal stimulator.

To compare the efficacy of the L300 with a conventional AFO or orthopedic shoes
with regard to walking capacity in stroke patients suffering from a drop foot.

A comparative, self-controlled study in which walking with the L300 will be
compared to walking with AFO or Orthopedic Shoes.

Use of peroneal stimulator Ness type L300 during 9 weeks. This device has a
good fit ('one size fits all' principle) with constant positioning of 2
independent active electrodes. It has a very robust and reliable foot switch
system that wirelessly communicates with the stimulation device mounted at the
proximal side of the lower leg (just below the knee joint). The mode of
electrical stimulation is such that patients can tolerate whole day use. The
patient is able to don and doff the system independently.
In case of effectiveness (one of the functional goals attained, no
complications and patient is compliant and satisfied with the use of L300) the
duration of the intervention is prolonged to 12 months.

The burden consist of an intake visit with physical examination, a pre- and
post-assessment consisting of walking tests, walking activity monitoring
(during 7 days at home). Patients will use the L300 for 9 weeks with weekly
control visits to the physiotherapist. During the whole study period subjects
will keep a diary for recording fall- and near-fall accidents.
Participants wearing the L300 for 1 year will have 2 additional follow-up
visits (post-assessments) at 6 and 12 months after inclusion.
The risks consist of a potential allergic reaction to stimulation and some
muscle soreness in the beginning of the use of the L300. All adverse reactions
are temporary.