Wearable Sensory Prosthesis for Peripheral Neuropathy

Overseen By Hannah Grimes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RxFunction Inc.

Disqualifiers: Under 60, No PN, Thrombophlebitis, Vascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sutton B Richmond, PhD

Principal Investigator

RxFunction Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Be willing to participate in all aspects of physical activity monitoring and study assessments

I am 60 years old or older.

I have PN and have lost feeling in the soles of my feet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a battery of instrumented mobility assessments, questionnaires, and a 10-day habitual physical activity observation period.

2 weeks

3 visits (in-person)

Treatment

Participants wear Walkasins for 10 weeks as part of their daily routine and are monitored with an activPAL activity monitor.

10 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of physical activity and balance.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Walkasins Users Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

RxFunction Inc.

Lead Sponsor

Trials

3

Recruited

110+

Brooks Rehabilitation

Collaborator

Trials

16

Recruited

1,900+