Restoring foot sensation to improve walking and multitasking
Somatosensory Feedback to Improve Neural Control of Walking in Older Adults
This project will test whether a wearable leg sensory device called Walkasins helps older adults with reduced foot sensation walk more automatically, with steadier gait and less thinking when doing another task.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 65 Years to 95 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06975423 on ClinicalTrials.gov |
What this trial studies
Older adults (65–95) with impaired foot sensation and slower walking speeds will wear an active or inactive Walkasins lower-limb neuroprosthesis while completing walking and dual-task challenges at the University of Florida. The study compares walking performance, gait variability, and prefrontal brain activity between the active and inactive device conditions to measure changes in cognitive load and automaticity. Participants must meet vision, blood pressure, and cognitive (MoCA ≥ 26) criteria and have documented loss of protective foot sensation on a 10 g monofilament test. Findings will test whether augmenting peripheral sensory input during walking can reduce cognitive demand and improve stability in complex environments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65–95 with documented foot sensory impairment on a 10 g monofilament, preferred walking speed under 1.0 m/s, MoCA score ≥ 26, adequate vision (≥ 20/70), and no major neurological or medical exclusions.
Not a fit: Patients with central neurological disorders (e.g., stroke, Parkinson’s, dementia), severe arthritis or other musculoskeletal limitations, significant vision loss, cognitive impairment (MoCA < 26), or intact foot sensation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, using Walkasins could make walking more automatic and steady for older adults with foot sensory loss, potentially lowering fall risk and improving confidence in everyday environments.
How similar studies have performed: Smaller prior studies of Walkasins and related sensory neuroprostheses have reported improvements in balance and gait for people with peripheral sensory loss, but applying this approach specifically to dual-task automaticity in older adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gainesville, Florida
- Clinical and Translational Research Building — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Shravani Chobhe
- Email: shravani.chobhe@neurology.ufl.edu
- Phone: (352) 294-5858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.