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

Recruiting now · Not applicable

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

In brief

The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy. Participants will do the following as part of the study: * Complete a sensation and balance assessment to determine eligibility for the study. * Answer questions about their medical history, physical function, balance confidence, and sleep. * Perform various balance and walking tasks on three separate occasions. One of the tests involves walking for six minutes without a cane or walker. * Wear an activPAL activity monitor for ten days on three separate occasions and return it to the researcher as directed. * Wear Walkasins for ten weeks as part of their daily routine. Walkasins consists of two parts: 1) an insole that fits inside the shoe and 2) a strap that secures around the ankle.

Key facts

Study ID

NCT07554443

Run by

RxFunction Inc.

People needed

18

Starts

2026-06-25

Expected to finish

2027-12-01

Last updated by the study team

2026-06-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brooks Rehabilitation Center — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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