Walking Sensation Study

NCT06975423 | Recruiting DMC FDA Device

• 2 other identifiers: IRB2025006325P30AG028740
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Dual-task walking; Brain activity; Walking performance

Outcome Measures

Primary Outcomes (3)

• Dual-Task Cost

  Comparison of dual-task walking performance between active and inactive lower-limb neuroprosthesis conditions

  Baseline, 7-day follow-up

• Gait Variability

  Comparison of gait performance between active and inactive lower-limb neuroprosthesis conditions.

  Baseline, 7-day follow-up

• Brain Activity

  Comparison of prefrontal cortical activity during active versus inactive lower-limb neuroprosthesis conditions.

  Baseline, 7-day follow-up

Secondary Outcomes (1)

• Kinematic and Dynamic Movement

  Baseline, 7-day follow-up

Study Arms (2)

Active lower-limb neuroprosthesis

ACTIVE COMPARATOR

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

Device: Active lower-limb neuroprosthesis

Inactive lower-limb neuroprosthesis

SHAM COMPARATOR

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

Device: Inactive lower-limb neuroprosthesis

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

Active lower-limb neuroprosthesis

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

Inactive lower-limb neuroprosthesis

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• The Claude D. Pepper Older Americans Independence Centers: collaborator
• University of Florida: lead

Study Sites (1)

Clinical and Translational Research Building

Gainesville, Florida, 32610, United States

RECRUITING

Central Study Contacts

Shravani Chobhe

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 16, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

US (1)