walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis
Condition: Sensory Peripheral Neuropathy; Balance; Distorted; Sensation Disorders
MeSH terms: Peripheral Nervous System Diseases; Sensation Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the long-term effects of Walkasins® use on
      clinical and subject-reported outcomes of balance and gait function, quality of life,
      physical activity/participation, pain, and medication use in persons with peripheral
      neuropathy who experience balance problems.
    

Detailed description: 
      The main objectives of this single-arm study are to show a long-term (10 weeks), sustained
      improvement in Functional Gait Assessment (FGA) score >4 following Walkasins use as compared
      to participants' initial baseline assessments and to examine a potential relationship between
      initial baseline assessment data and long-term outcomes. The previous finding of a short-term
      FGA change >4 during Walkasins use (NCT02115633) justifies a pre-post study design to
      investigate the long-term effects of Walkasins use. Although the primary timeframe for the
      primary endpoint is 10 weeks, participants will return for follow-up visits at 26 weeks and
      52 weeks 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 randomized cross-over replication will occur only during the baseline visit. The
      long-term study consists of a single arm.) This study may help to further refine the
      prescription criteria for Walkasins and determine whether or not the presence of a short-term
      response is indicative of long-term improvements.

      A subset of 10 participants at the Harvard Medical School site will be enrolled in a pilot
      study to investigate possible structural and functional changes in cortical areas of the
      brain related to somatosensory connectivity using magnetic resonance imaging (MRI).
      Structural as well as functional MRI scans will be acquired at baseline and after 26 weeks of
      daily Walkasins use. An exploratory analysis of MRI data will be performed and related to
      functional clinical outcomes associated with Walkasins use over the same time period.
    

Intervention name(s): Walkasins
Intervention type(s): Device
Intervention description(s): Walkasins® consist of two parts for each leg: the Haptic Module (leg unit) and the Receptor Sole (foot pad). The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomized only during the baseline visit.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Balance; Peripheral Neuropathy; Neuropathy