Wearable sensory prosthesis to improve coordination, walking, and activity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, within-subject study evaluates whether a lower-limb sensory prosthesis (Walkasins) can improve gait quality and habitual physical activity in adults with peripheral neuropathy and plantar sensory loss. Participants undergo baseline mobility assessments and 10-day activity monitoring, then use Walkasins for 10 weeks with repeated assessments to compare with their own baseline. The study uses instrumented tests such as 6-minute walk and Functional Gait Assessment, along with questionnaires and activity logs, to determine changes in mobility and daily activity. Eligible participants are 60 years or older with PN, balance impairment, and the ability to walk 6 minutes without an assistive device. The lead sponsor is RxFunction Inc., with Brooks Rehabilitation as a collaborator at the Jacksonville, Florida site.

Why it matters

Who can join: the full rules

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

Where it's running

• Brooks Rehabilitation Center
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Dorian Rose, PT, MS, PhD, FAPTA
• Email: research@rxfunction.com
• Phone: 352-273-8307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.