Medical Device Clinical Trial:

Improving Gait and Balance in Patients with Sensory Peripheral Neuropathy

Project Overview

In this project, I contributed to the walk2Wellness trial, a comprehensive study focused on evaluating the user experience, usability, and effectiveness of Walkasins®—a wearable sensory prosthesis designed for patients with sensory peripheral neuropathy (PN). Our goal was to understand how long-term use of this device could improve gait, balance, and quality of life while also gathering insights into user satisfaction and engagement with the hardware.

User Experience Research Objectives

The study was designed with a dual focus:

  1. Quantitative Analysis: Measure the impact of Walkasins® on functional gait, balance, and fall rates through clinical outcomes.

  2. Qualitative Insights: Gather user feedback on the device's usability, comfort, and overall experience to inform future design improvements.

Background

Patients with PN often suffer from reduced plantar sensation, leading to significant challenges in balance and gait, which increases their risk of falls. The Walkasins® device aims to mitigate these issues by providing directional tactile feedback based on plantar pressure measurements, essentially substituting for the lost nerve function. Our research sought to assess both the clinical efficacy of the device and the user experience, focusing on how patients interacted with and benefited from this novel technology.

Methods

Participant Selection: Participants were chosen based on:

  • A diagnosis of PN with significant loss of plantar sensation

  • Existing gait and balance issues

  • High fall risk (FGA score < 23)

  • Ability to perceive tactile stimuli above the ankle, ensuring they could respond to the device's cues

Quantitative Research

  • Clinical Assessments: FGA, Gait Speed, Timed Up & Go (TUG), and the 4-Stage Balance Test were used to quantify improvements in mobility.

  • Patient-Reported Outcomes: Scales such as the Activities-Specific Balance Confidence (ABC) and PROMIS were used to capture participants' confidence and satisfaction with their daily activities.

Qualitative Research

  • User Interviews: Participants provided detailed feedback on their experience with the device, including comfort, ease of use, and perceived effectiveness.

  • Usability Testing: Observations were made during clinic visits to assess how participants interacted with the device, including donning and doffing, adjusting settings, and responding to the tactile cues during walking.

Key Findings

Quantitative Outcomes

  • Functional Gait Assessment (FGA): There was a significant improvement, with scores increasing from 15.0 to 19.1 (p < 0.0001).

  • Gait Speed: Notable improvements in both normal and fast gait speeds were recorded.

  • Timed Up & Go (TUG): Performance improved from 13.8 seconds to 12.5 seconds (p = 0.012).

  • Balance Tests: While the 4-Stage Balance Test did not show significant change, the reduction in fall risk factors and fall rate was significant, especially among those who had a history of falls.

Qualitative Outcomes

  • User Feedback: Participants generally found the device to be comfortable and easy to integrate into their daily routines. However, some reported initial difficulties in adjusting to the tactile cues, which improved with continued use.

  • Usability: The design of the Walkasins® hardware was well-received, with users appreciating its lightweight and discreet form. Some suggestions for improvement included more customizable tactile feedback settings and clearer instructions for first-time users.

Conclusion

This project demonstrated that Walkasins® is not only effective in improving gait and reducing fall risks in PN patients but also well-received in terms of user experience and hardware usability. The combination of quantitative data and qualitative feedback provided a comprehensive understanding of the device's impact, highlighting areas for future improvement in user interface and experience design.

Final Thoughts

This case study showcases my expertise in user experience research within a clinical setting, emphasizing the importance of balancing quantitative outcomes with qualitative user insights to drive the development of effective and user-friendly medical devices.