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

RxFunction Inc. · with Brooks Rehabilitation · NCT07554443

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
18
US sites recruiting
1
Study start
June 25, 2026
Record last updated
June 25, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: External, lower limb sensory prosthesis

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Brooks Rehabilitation Center

    Jacksonville, FL 32216

    Site contact: Mark B Bowden, PhD · 904.345.6626 · research@rxfunction.com

Study contacts (from the official record)

  • Dorian Rose, PT, MS, PhD, FAPTA · 352-273-8307 · research@rxfunction.com
  • Hannah Grimes · 904-528-3159 · Hannah.Grimes@brooksrehab.org
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Wearable Sensory Prosthesis to Improve Coordination, Walking, and… (NCT07554443) | Bored Studies