Walking Sensation Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-95
SponsorUniversity of Florida
About this trial
The primary objective of this new line of research is to test whether augmenting sensory information from the legs, using Walkasins sensory neuroprosthesis, can enhance performance of a complex walking task in older adults with foot sensory impairment. The overarching hypothesis is that Walkasins will enhance the automaticity and reduce cognitive demand of walking in older adults with foot sensory impairments, as measured by reduced prefrontal activity, decreased dual-task costs, and lower gait variability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Not having any significant existing medical conditions, historical health issues, or medications (outlined in the
Disqualifiers
age 65 - 95.
no severe high blood pressure (systolic < 180 mmHg and/or diastolic < 100 mmHg at rest).
no severe vision impairment: visual acuity ≥ 20/70 as determined by Snellen eye chart.
slow walking speed: preferred walking speed slower than 1.0 m/s over 10 meter.
Trial design
Design model
Crossover
Treatments tested in this trial
Active lower-limb neuroprosthesis
DeviceWalkasins sensory neuroprosthesis provides real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle
Inactive lower-limb neuroprosthesis
DeviceWalkasins sensory neuroprosthesis does not provide real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active lower-limb neuroprosthesisActive comparator 1 intervention
Group B: Inactive lower-limb neuroprosthesisSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dual-Task Cost
Comparison of dual-task walking performance between active and inactive lower-limb neuroprosthesis conditions
Time frame
Baseline, 7-day follow-up2
Gait Variability
Comparison of gait performance between active and inactive lower-limb neuroprosthesis conditions.
Time frame
Baseline, 7-day follow-up3
Brain Activity
Comparison of prefrontal cortical activity during active versus inactive lower-limb neuroprosthesis conditions.
Time frame
Baseline, 7-day follow-upSecondary outcomes
1
Kinematic and Dynamic Movement
Comparison of kinematic and dynamic movement during active versus inactive lower-limb neuroprosthesis conditions.
Time frame
Baseline, 7-day follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
The Claude D. Pepper Older Americans Independence Centers
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov