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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
RxFunction Inc.
Study ID
NCT07554443
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • External, lower limb sensory prosthesis — DEVICE
    Walkasins is an external, lower limb sensory prosthesis intended to replace part of the nerve function used for detection and signaling of foot pressure sensation during standing and walking activities. Walkasins consist of two parts for each leg: the Haptic Module and the Receptor Sole. The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.

Study Details

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 Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Walkasins Users
    After the baseline visit and activity monitoring, users will receive Walkasins. They will use the device for 10 weeks during which they will also wear an activPAL activity monitor for ten days on at the beginning and end of their Walkasins use.

Primary Outcome Measure

Activity Score--Metabolic Equivalents (METs) [ Time Frame: Over a period of ~12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brooks Rehabilitation CenterJacksonvilleFlorida32216
Mark B Bowden, PhD
[email protected]
904.345.6626

Find similar trials in Jacksonville, FL

By research site
Brooks Rehabilitation Center· Jacksonville, FL

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