Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:8 - 17
Updated:5/20/2018
Start Date:July 2016
End Date:July 2022

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The purpose of this study is to investigate the use of the WalkAide, a Neuroprosthetic
device, on a child's ability to ascend/descend stairs and curbs. It is hypothesized that with
WalkAide use, the improved ankle control achieved, will affect the speed, symmetry, and
independence of completing the task.

The investigators will examine the use of the WalkAide, a Neuroprosthetic device, on a
child's ability to ascend/descend stairs and curbs. It is hypothesized that with WalkAide
use, the improved ankle control achieved, will affect the speed, symmetry, and independence
of completing the task.

Study subjects will be fitted with the WalkAide by Physical Therapists trained in this
procedure. Subjects will build tolerance to the device over a two-week period, and use as
able for the next six weeks. The children (participants/subjects) in the study will go
through a desensitization process to familiarize them with the electrical stimulation.

The children will begin with no stimulation, wearing the Walkaide to introduce the sensation
of the cuff on their leg prior to beginning the stimulation. Once familiar with the feel of
the Walkaide, the electrical stimulation will be introduced slowly and gradually. The child's
face and verbal responses will be monitored while the stimulation is introduced and turned up
to the desired response threshold.

An age and cognitively appropriate pain scale will be available if applicable to the child
and situation.

The children will be assured that if they do not want to continue or if they feel
uncomfortable, then the electrical stimulation will be turned off immediately. The minimum
stimulus intensity is determined in collaboration with each subject. The children are asked
to identify when they first begin to feel the stimulus, and the number on the intensity knob
is noted. The duration of the stimulus is gradually increased along with the wearing of the
Walkaide. Subjects will begin by wearing the prosthesis for 30 minutes. The wearing time will
be increased to waking hours of the subject, depending on their age. The electrodes will be
placed on the client before the session is to begin, and taken off immediately after WalkAide
usage. The skin will be checked before and after WalkAide electrode usage. The skin will be
cleaned with an alcohol wipe before the electrodes are applied. It is normal to observe
somewhat reddened areas under the electrode placement following usage. However, the redness
should disappear within an hour. With signs of irradiation or maintained redness, small
pimple like lesions or blisters, the WalkAide usage will be discontinued at that time, and
the patient will be brought to the medical staff. The skin will be re-evaluated an hour later
following the electrode usage. The Pediatrician for that patient will be immediately
notified, and the WalkAide usage discontinued until the problem is resolved.

Inclusion Criteria:

- Ability to ambulate independently with or without an assistive device and/or lower
extremity orthoses.

- Ability to follow and understand experimental procedures.

Exclusion Criteria:

- Seizure history interfering with use of functional electrical stimulation as verified
by their MD.

- Inability to be able to complete the assessment tests to gain a baseline score.

- Skin irritation/skin intact.

- Uncorrected vision impairments.
We found this trial at
1
site
Valhalla, New York 10595
Phone: 914-592-7138
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mi
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Valhalla, NY
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