A Smart Shoe Insole to Monitor Frail Older Adults’ Walking Speed: Results of Two Evaluation Phases Completed in a Living Lab and Through a 12-Week Pilot Study

Background Recent World Health Organization reports propose wearable devices to collect information on activity and walking speed as innovative health indicators. However, mainstream consumer-grade tracking devices and smartphone apps are often inaccurate and require long-term acceptability assessment. Objective Our aim is to assess the user acceptability of an instrumented shoe insole in frail older adults. This device monitors participants’ walking speed and differentiates active walking from shuffling after step length calibration. Methods A multiphase evaluation has been designed: 9 older adults were evaluated in a living lab for a day, 3 older adults were evaluated at home for a month, and a prospective randomized trial included 35 older adults at home for 3 months. A qualitative research design using face-to-face and phone semistructured interviews was performed. Our hypothesis was that this shoe insole was acceptable in monitoring long-term outdoor and indoor walking. The primary outcome was participants' acceptability, measured by a qualitative questionnaire and average time of insole wearing per day. The secondary outcome described physical frailty evolution in both groups. Results Living lab results confirmed the importance of a multiphase design study with participant involvement. Participants proposed insole modifications. Overall acceptability had mixed results: low scores for reliability (2.1 out of 6) and high scores for usability (4.3 out of 6) outcomes. The calibration phase raised no particular concern. During the field test, a majority of participants (mean age 79 years) were very (10/16) or quite satisfied (3/16) with the insole's comfort at the end of the follow-up. Participant insole acceptability evolved as follows: 63% (12/19) at 1 month, 50% (9/18) at 2 months, and 75% (12/16) at 3 months. A total of 9 participants in the intervention group discontinued the intervention because of technical issues. All participants equipped for more than a week reported wearing the insole every day at 1 month, 83% (15/18) at 2 months, and 94% (15/16) at 3 months for 5.8, 6.3, and 5.1 hours per day, respectively. Insole data confirmed that participants effectively wore the insole without significant decline during follow-up for an average of 13.5 days per 4 months and 5.6 hours per day. For secondary end points, the change in frailty parameters or quality of life did not differ for those randomly assigned to the intervention group compared to usual care. Conclusions Our study reports acceptability data on an instrumented insole in indoor and outdoor walking with remote monitoring in frail older adults under real-life conditions. To date, there is limited data in this population set. This thin instrumentation, including a flexible battery, was a technical challenge and seems to provide an acceptable solution over time that is valued by participants. However, users still raised certain acceptability issues. Given the growing interest in wearable health care devices, these results will be useful for future developments. Trial Registration ClinicalTrials.gov NCT02316600; https://clinicaltrials.gov/ct2/show/NCT02316600