Recruiting

WalkasinsWalking Sensation Study

Sponsor:

University of Florida

Code:

NCT06975423

Conditions

Aging

Sensory Deficit

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Active lower-limb neuroprosthesis

Inactive lower-limb neuroprosthesis

Study Details

Brief summary:

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.

Conditions

Aging

Sensory Deficit

Study ID

NCT06975423

Start date

Sep 8, 2025

Status verified date

Sep, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Not having any significant existing medical conditions, historical health issues, or medications (outlined in the exclusion criteria table above) that could impede the execution of the walking task and assessment.
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.
no cognitive impairment: Montreal Cognitive Assessment (MoCA) score ≥ 26 out of 30 possible points.
foot sensory impairment: Inability to feel the 10 g monofilament at ≥1 of 10 tested sites on either foot is considered a sign of impaired protective sensation. loss.

Exclusion Criteria:

diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
severe arthritis, such as awaiting joint replacement
current cardiovascular, lung or renal disease; untreated diabetes; terminal illness
myocardial infarction or major heart surgery in the previous year
cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
currently taking medications that affect the central nervous system, such as benzodiazepines, anti-cholinergic medication, and GABAergic medication, among others
no severe vision impairment (visual acuity ≥ 20/70 as determined by Snellen eye chart)
uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
bone fracture or joint replacement in the previous six months
current enrollment in any other clinical trial
planning to relocate out of the area during the study period
non-English\* speaking, due to the likelihood of difficulties following instructions and communicating remotely
clinical judgment of the investigative team

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Active lower-limb neuroprosthesis

Walkasins sensory neuroprosthesis provides real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle

Inactive lower-limb neuroprosthesis

Walkasins sensory neuroprosthesis does not provide real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle

Primary outcome measure

Dual-Task Cost [ Time Frame: Baseline, 7-day follow-up ]
Gait Variability [ Time Frame: Baseline, 7-day follow-up ]
Brain Activity [ Time Frame: Baseline, 7-day follow-up ]

Central Contacts and Locations

Central contacts

Shravani Chobhe

(352) 294-5858 shravani.chobhe@neurology.ufl.edu

Locations

Clinical and Translational Research Building

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Casey Stauffer

352-273-8157 caseystauffer@ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 4, 2026

Last verified

Sep, 2025

Keywords

Dual-task walking
Brain activity
Walking performance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-04.