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Walking Sensation Study

Somatosensory Feedback to Improve Neural Control of Walking in Older Adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06975423
Enrollment
30
Registered
2025-05-16
Start date
2025-09-08
Completion date
2027-03-31
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Sensory Deficit

Keywords

Dual-task walking, Brain activity, Walking performance

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.

Detailed description

Preserving mobility function in older adults is crucial for ensuring safe walking in complex environments, including home and community settings. A common example is navigating a busy street with obstacles like uneven sidewalks and pedestrians, or a home with furniture, stairs, and narrow hallways, all while engaging in a conversation or mental task. Such environments create a potential risk for older adults, who may show declines in function across multiple systems, including sensation, cognition, and mobility. Successfully walking in complex environments depends on cognitive control processes, such as attention and motor planning, which rely on sufficient sensory information from peripheral receptors. Somatosensory impairment, particularly in the feet, is common among older adults and tends to increase progressively with age, often worsened by the presence of certain diseases. Age-related somatosensory impairments disrupt essential input to central motor and cognitive networks, raising the risk of accidental collisions, slips, trips, and injurious falls. Older adults may compensate by increasing cognitive load (attention and executive control of movement). However, this shift may overburden cognitive systems, again raising the risk of collisions, slips, trips, and falls. There is a critical, yet underexplored, need to restore somatosensory input to the nervous system during walking in older adults with foot sensory impairments. Therefore, the objective of this study is to investigate whether the use of a novel lower-limb sensory prosthesis, Walkasins, improves complex walking performance and reduces cognitive load. This crossover study will enroll 30 participants with foot sensory impairment, who will undergo complex walking performance assessments while wearing the Walkasins in both the "on" and "off" settings. These settings will be assessed in separate visits occurring at least one week apart, to allow for a washout period. The walking course will use a pressure-sensitive instrumented walkway to analyze kinetic and kinematic variability of the gait pattern. These assessments will include typical walking, as well as dual-task walking with and without obstacle crossing as a behavioral assessment of cognitive load. Furthermore, cognitive load will be assessed by measuring prefrontal cortical activity with functional near infrared spectroscopy (fNIRS). We will address the following specific aims: Specific Aim 1 is to test whether Walkasins can improve walking performance, hypothesizing greater reductions in dual-task costs and gait variability when using Walkasins in the "on" setting compared to the "off" setting. Specific Aim 2 is to assess the potential of Walkasins to reduce cognitive load during walking, hypothesizing lower prefrontal cortical activity when using Walkasins in the "on" setting compared to the "off" setting. This pilot study enhances our understanding of age-related sensory impairments in neural control and walking performance and will prepare us for larger-scale trials with more intervention sessions, larger sample sizes, and a focus on the underlying neurophysiological mechanisms. This study and future research contribute to the development of rehabilitation strategies that support healthy aging and enhance functional mobility.

Interventions

DEVICEActive lower-limb neuroprosthesis

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

DEVICEInactive lower-limb neuroprosthesis

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

Sponsors

University of Florida
Lead SponsorOTHER
The Claude D. Pepper Older Americans Independence Centers
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Dual-Task CostBaseline, 7-day follow-upComparison of dual-task walking performance between active and inactive lower-limb neuroprosthesis conditions
Gait VariabilityBaseline, 7-day follow-upComparison of gait performance between active and inactive lower-limb neuroprosthesis conditions.
Brain ActivityBaseline, 7-day follow-upComparison of prefrontal cortical activity during active versus inactive lower-limb neuroprosthesis conditions.

Secondary

MeasureTime frameDescription
Kinematic and Dynamic MovementBaseline, 7-day follow-upComparison of kinematic and dynamic movement during active versus inactive lower-limb neuroprosthesis conditions.

Countries

United States

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026