walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis

The main objective of the current study is to show a long-term (10 weeks) sustained
improvement in FGA score >4 following walkasins use as compared to initial baseline
assessment and to examine a potential relationship between initial baseline assessment data
and long-term outcome. The finding of a short-term FGA change >4 during walkasins® use
justifies a pre-post study design to investigate the long-term effects of walkasins use.

The investigators also intend to extend their observations of the short-term effects of
walkasins by replicating the randomized cross-over design of a previous short-term study.
(The replication will occur during the baseline visit.) This study will help to further
refine the prescription criteria for walkasins and determine whether the presence of a
short-term response is indicative of long-term improvements or not.

Inclusion Criteria:

- Age: 18-90 years, male or female

- Formal diagnosis of sensory peripheral neuropathy prior to participating in the study

- Self-reported balance problems

- Ability for transfers or ambulation on level surfaces at fixed cadence as assessed by
the physical therapist during the FGA

- FGA <23, the cut-off score for high fall-risk

- Ability to understand and provide informed consent

- Foot size that allows the walkasins® to function appropriately (women's size 5 through
men's size 12)

- Must be able to complete all functional outcome measures without the use of an
assistive device

Exclusion Criteria:

- Inability to perceive vibration from walkasins® leg unit

- Use of ankle-foot orthosis for ambulation that prevents donning of walkasins®

- Open wounds on the foot or calf as determined by clinician assessing risk

- Musculoskeletal or other neurological conditions that prohibit use of walkasins® as
determined by clinician

- Weighs more than 300 pounds

- Plans to begin balance physical therapy (PT) during the clinical trial
(Ongoing/current or previous balance PT is not an exclusionary criterion.)