Recruiting

Walkasins

Sponsor:

RxFunction Inc.

Code:

NCT07554443

Conditions

Peripheral Neuropathy With Type 2 Diabetes

Peripheral Neuropathy Grade 2 or Greater

Balance

Balance Impairment, Gait Disorders, Fatigue

Balance Disorders

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

External, lower limb sensory prosthesis

Study Details

Brief summary:

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.

Conditions

Peripheral Neuropathy With Type 2 Diabetes

Peripheral Neuropathy Grade 2 or Greater

Balance

Balance Impairment, Gait Disorders, Fatigue

Balance Disorders

Study ID

NCT07554443

Start date

Jun 25, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

External, lower limb sensory prosthesis

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.

Primary outcome measure

  • Activity Score--Metabolic Equivalents (METs) [ Time Frame: Over a period of ~12 weeks ]
  • Step Count [ Time Frame: Over a period of ~12 weeks ]
  • Total Sedentary Time [ Time Frame: Over a period of ~12 weeks ]
  • 6-Minute Walk Test--Phase Coordination Index (PCI) [ Time Frame: Baseline, Walkasins Initiation, Follow-up (Week 10) ]

Central Contacts and Locations

Central contacts

Dorian Rose, PT, MS, PhD, FAPTA

352-273-8307research@rxfunction.com

Hannah Grimes

904-528-3159Hannah.Grimes@brooksrehab.org

Locations

Brooks Rehabilitation Center

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Mark B Bowden, PhD

904.345.6626research@rxfunction.com

More Information

Sponsor

RxFunction Inc.

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Peripheral Neuropathy
  • Walkasins
  • Balance Disorders
  • Physical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by RxFunction Inc. on 2026-06-25.