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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorRxFunction Inc.

About 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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • External, lower limb sensory prosthesis

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

RxFunction Inc.

Lead sponsor

Brooks Rehabilitation

Collaborator