Usability Test

We are designing a clinical study with the user as the subject and verifying the safety and validity via statistical data analysis.

In addition, we verify usability and determine solutions for improvement through user observation and interview analysis.

Case: Medical wearable robot HMEX, clinical study performed at H University hospital

1. Purpose

- To assess safety and validity of medical wearable robots as walking assistance devices for paraplegic patients

- To observe users, verify usability through interviews, and determine improvement measures

2. Clinical Trial Design

- By reviewing numerous literature and through an agreement with the hospital, a clinical study protocol will be developed including test method, duration, time, frequency, etc.

- Selection of a walking feature, physiological feature and subjective satisfaction measurement index to validate effectiveness

- Development of user observation and interview protocols

3. Clinical Study Performance

- Perform a clinical study with actual patients as subjects for several months

- Data collected in the following areas before and after the clinical study: ① walking function ② physiological function (muscle stiffness, lung function, intestinal function, etc.) ③ subjective satisfaction

- Collection of observation-based errors and their frequency

4. Results Analysis

① Analysis of Clinical Data

- Statistical analysis of data regarding walking functions, physiological functions, and subjective satisfaction before and after the study

- Verification of positive changes regarding bodily function, health status, muscle stiffness, and pain in paraplegic patients

② Analysis of User Observation and Interview Data

- Analysis of major errors, definition and categorization of error types

- Analysis of error frequency by category for initial-midterm-long term clinical trials to determine major usability issues

- Analyzing causes of errors based on interview data and determining measures for improving usability