AgingNCT06975423
Walking Sensation Study
A study testing Active lower-limb neuroprosthesis and Inactive lower-limb neuroprosthesis in people with Aging and Sensory Deficit, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Sensory Deficit
- What is being tested?
- Active lower-limb neuroprosthesis and Inactive lower-limb neuroprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical and Translational Research Building
Gainesville, Florida, 32610
Casey Stauffer, 352-273-8157, caseystauffer@ufl.edu
About this study
Official title: Somatosensory Feedback to Improve Neural Control of Walking in Older Adults
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.
Read the 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.
- Conditions
- Aging, Sensory Deficit
- Being tested
- Active lower-limb neuroprosthesis, Inactive lower-limb neuroprosthesis
- Keywords
- Dual-task walking, Brain activity, Walking performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active lower-limb neuroprosthesisDevice
Walkasins sensory neuroprosthesis provides real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle
Inactive lower-limb neuroprosthesisDevice
Walkasins sensory neuroprosthesis does not provide real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Inactive lower-limb neuroprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-Task Cost
Comparison of dual-task walking performance between active and inactive lower-limb neuroprosthesis conditions
Measured: Baseline, 7-day follow-up
Gait Variability
Comparison of gait performance between active and inactive lower-limb neuroprosthesis conditions.
Measured: Baseline, 7-day follow-up
Brain Activity
Comparison of prefrontal cortical activity during active versus inactive lower-limb neuroprosthesis conditions.
Measured: Baseline, 7-day follow-up
Secondary outcomes (1)
Kinematic and Dynamic Movement
Comparison of kinematic and dynamic movement during active versus inactive lower-limb neuroprosthesis conditions.
Measured: Baseline, 7-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 Sep 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975423
- Sponsor's protocol ID
- IRB202500632
- Other IDs
- 5P30AG028740
- Status last verified
- Oct 2026
- First submitted
- 7 May 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Feedback to Improve Neural Control of Walking in Older Adults
- ClinicalTrials.gov ID
- NCT06975423
- Acronym / sponsor ID
- IRB202500632
- Conditions
- Aging, Sensory Deficit
- Keywords
- Dual-task walking, Brain activity, Walking performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active lower-limb neuroprosthesis | Active comparator | Device: Active lower-limb neuroprosthesisParticipants 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 |
| Inactive lower-limb neuroprosthesis | Sham comparator | Device: Inactive lower-limb neuroprosthesisParticipants 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 |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active lower-limb neuroprosthesisWalkasins sensory neuroprosthesis provides real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle | Device | Active lower-limb neuroprosthesis |
| Inactive lower-limb neuroprosthesisWalkasins sensory neuroprosthesis does not provide real-time sensory input by delivering vibrotactile stimuli to the lower limbs above the ankle | Device | Inactive lower-limb neuroprosthesis |
Primary outcome
Dual-Task Cost
Time frame: Baseline, 7-day follow-up
Comparison of dual-task walking performance between active and inactive lower-limb neuroprosthesis conditions
Gait Variability
Time frame: Baseline, 7-day follow-up
Comparison of gait performance between active and inactive lower-limb neuroprosthesis conditions.
Brain Activity
Time frame: Baseline, 7-day follow-up
Comparison of prefrontal cortical activity during active versus inactive lower-limb neuroprosthesis conditions.
1 secondary outcome
Kinematic and Dynamic Movement
Time frame: Baseline, 7-day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active lower-limb neuroprosthesis and Inactive lower-limb neuroprosthesis in people with Aging and Sensory Deficit, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shravani Chobhe ((352) 294-5858, shravani.chobhe@neurology.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-Task Cost (time frame: Baseline, 7-day follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.