Walking Sensation Study

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06975423
Status
Recruiting
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Conditions

  • Aging
  • Sensory Deficit

Eligibility Criteria

Sex
ALL
Age
65 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • Active lower-limb neuroprosthesis — DEVICE
    Walkasins sensory neuroprosthesis provides real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle
  • Inactive lower-limb neuroprosthesis — DEVICE
    Walkasins sensory neuroprosthesis does not provide real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle

Study Details

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.

Key Dates

Start date
Sep 8, 2025
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active lower-limb neuroprosthesis
    Participants will perform single- and dual-task walking trials, including Serial 7 Subtraction, with and without navigating wide and high obstacles (to increase cognitive effort), while wearing Walkasins in "ON" setting
  • Sham Comparator: Inactive lower-limb neuroprosthesis
    Participants will perform single- and dual-task walking trials, including Serial 7 Subtraction, with and without navigating wide and high obstacles (to increase cognitive effort), while wearing Walkasins in "OFF" setting

Primary Outcome Measure

Dual-Task Cost [ Time Frame: Baseline, 7-day follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical and Translational Research BuildingGainesvilleFlorida32610
Casey Stauffer
[email protected]
352-273-8157

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By research site
Clinical and Translational Research Building· Gainesville, FL

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