Dropfoot Clinical Trial
Official title:
The Evaluation of Dual Channel vs Single Channel FES for Dropfoot
20 users of Ness L300, FES device for ankle dorsiflexion will wear the same FES cuff, yet instead of a single channel stimulation, they will be stimulated with two channels. the purpose of the dual channel stimulation is to enable a balanced dorsiflexion, with no inversion/eversion movements. the stimulation will be recorded both in a seated position and during gait
twenty subjects will be stimulated with a single channel electrode, the Quick Fit Electrode.
the values of stimulation will be recorded, as well as ankle movement (balanced
Dorsiflexion, inverted or everted Dorsiflexion). Subjects will fill up a Benefit,
Satisfaction, Willingness to continue (BSW) form. Next, subjects will be fitted with a
segmented Electrode that enables both single and dual channel. Four configurations of
current will be compared during sitting position and during gait. The first configuration
(A) is segmented electrode single channel stimulation, the second configuration (B) is two
currents running in parallel. The first medial channel stimulates the deep branch of common
peroneal nerve (dorsiflexion/inversion) and the second lateral current stimulates the
superficial peroneal nerve (eversion). In the third configuration (C), channels run
diagonally. The medial channel runs between the upper medial electrode and the lateral lower
electrode (dorsiflexion/inversion). The lateral channel runs between the lateral upper
electrode and the medial lower electrode (eversion). The forth configuration (D) includes a
common lower electrode; when it is connected to the upper medial electrode it functions as a
medial channel (dorsiflexion/inversion); when it is connected to the upper lateral
electrode, it functions as the lateral channel (eversion). The subjects will be asked to
answer 3 questions after trying each configuration. 1. Thinking of the current system you
use, did this test system provide any difference in the way the stimulation feels compared
to your existing system? Yes No/Cannot tell any difference. 2. Thinking of the current
system you use, did this test system provide any difference in what you think of as the
'quality' of stimulation you are used to compared to your existing system? Yes No/Cannot
tell any difference. 3. Thinking of the current system you use, did this test system provide
any difference in your ability to walk compared to your existing system? Yes No/Cannot tell
any difference After all three dual channel configurations have been tested, subjects will
be asked Question 4: Thinking of the last three test systems you used today, which test
system do you believe was best among the three? B, C or D Subjects will be asked to grade
their satisfaction with the one dual channel system they believe is best using the Benefit,
Satisfaction, Willingness to Continue (BSW) questionnaire.
Phase II of the trial will be a re-evaluation of 10 subjects. The anode/cathode electrodes
will be re-positioned so the cathodes will be located at the upper part of the cuff and the
anodes will be located at the lower part of the cuff. Stimulation will be given while
sitting and during 2 minutes walk. Ankle movement and stimulation intensity will be recorded
and compared to the input in phase I for the same users.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment