Back to search results

Wearable Sensory Prosthesis for Peripheral Neuropathy

This study is looking at whether a device called Walkasins® can help people with peripheral neuropathy (nerve damage that can cause weakness, numbness, and pain, usually in your hands and feet) improve their balance, walking, and physical activity. Walkasins® is a wearable device for your lower legs that aims to help with foot pressure sensation. The study will enroll 18 participants aged 60 or older who have peripheral neuropathy with sensory loss and balance problems. To be eligible, you must also be able to walk independently for at least 6 minutes. Researchers will measure your activity levels, step count, and how much time you spend sitting over about 12 weeks to see if the Walkasins® device helps.

Study design
This study will involve 18 participants and will compare each person's activity levels before and after using the Walkasins® device. It is designed to take place over one year.
What's involved
You will complete assessments of your sensation and balance, answer questions about your health, and perform balance and walking tasks. You will also wear an electronic device for 10 days to track your activity before using Walkasins®, and again after you start using the device and have gotten used to it.
Compensation
Not stated in the trial record.
Follow-up
Your activity levels, step count, and sedentary time will be measured over a period of approximately 12 weeks after you start using the device.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07554443

Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity

Recruiting
NAAges 60+Interventional
RxFunction Inc.
~18 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:External, lower limb sensory prosthesis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Activity Score--Metabolic Equivalents (METs)
Measured over Over a period of ~12 weeks
+3 more outcomes measured

Conditions

Peripheral Neuropathy With Type 2 Diabetes
Peripheral Neuropathy Grade 2 or Greater
Balance
Balance Impairment, Gait Disorders, Fatigue
Balance Disorders
Physical Activities

Explore related trials

Gait DisturbanceImpaired BalancePeripheral Neuropathy

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Sutton B Richmond, PhD · STUDY_DIRECTOR · RxFunction Inc.

Who to contact

Dorian Rose, PT, MS, PhD, FAPTA
[email protected]
352-273-8307
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Be 60 years of age or older
Have a diagnosis of PN with plantar sensory loss
Demonstrate balance impairment, defined as a Single-Leg Stance time of \<23 seconds
Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)
Be willing to use the Walkasins device as recommended
Be willing to participate in all aspects of physical activity monitoring and study assessments

Exclusion

Under 60 years old
Do not have a diagnosis of PN with plantar sensory loss
Self-reported acute thrombophlebitis, including deep vein thrombosis
Self-reported severe peripheral vascular disease
Untreated lymphedema
Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
Self-reported, untreated fractures in the foot and ankle
Other neurological or musculoskeletal conditions that moderately or severely impact walking
Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
Weight of more than 300 pounds
Inability to perceive vibration from Walkasins Haptic Module
Do not demonstrate balance impairments, defined as a Single-Leg Stance time of \<23 seconds

What this trial measures

  • Activity Score--Metabolic Equivalents (METs)Over a period of ~12 weeks

    The Activity Score, expressed in metabolic equivalents (METs), reflects the overall intensity of physical activity performed. (One MET is defined as the energy a person uses when resting or sitting still.) Higher MET values indicate greater energy expenditure and higher levels of physical activity, while lower values suggest reduced activity intensity and increased sedentary behavior.

  • Step CountOver a period of ~12 weeks

    Step count reflects the total number of steps accumulated over a given period and serves as an indicator of overall daily ambulatory activity. Lower step counts are associated with reduced physical activity levels and decreased functional mobility.

  • Total Sedentary TimeOver a period of ~12 weeks

    Total sedentary time reflects the individual's overall inactivity during the day. Prolonged sedentary behavior may contribute to deconditioning, decreased functional capacity, and increased risk for chronic disease.

  • 6-Minute Walk Test--Phase Coordination Index (PCI)Baseline, Walkasins Initiation, Follow-up (Week 10)

    The 6 Minute Walk Test is an exercise test used to evaluate aerobic capacity and endurance. The distance a subject walks in six minutes is the outcome by which to compare changes in performance capacity. Participants will wear sensors during the test that will allow for calculation of Phase Coordination Index (PCI) scores. A PCI score closer to zero indicates better bilateral coordination or better phase generation accuracy and/or consistency within the gait cycle.