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RECRUITING

NCT06975423

Walking Sensation Study

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

Official title: Somatosensory Feedback to Improve Neural Control of Walking in Older Adults

Key Details

Gender

All

Age Range

65 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-08

Completion Date

2027-03-31

Last Updated

2026-02-09

Healthy Volunteers

Yes

Conditions

Aging Sensory Deficit

Interventions

DEVICE

Active lower-limb neuroprosthesis

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

DEVICE

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

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

Locations (1)

Clinical and Translational Research Building

Gainesville, Florida, United States