Compact Orthosis Compliance Monitoring Device Using Pressure Sensors and Accelerometers: Design and Proof-of-Concept Testing.

Monitoring orthosis compliance using patient diaries is subjective, as patients can overestimate their levels of device use. An objective way to monitor compliance is required because if an orthotic prescription is not followed, the orthosis will not work as intended. This study aimed to develop and validate a device that monitors orthosis compliance objectively using pressure and acceleration. Fifteen participants were recruited to test the device's ability to estimate wear time during the performance of several grip patterns and whilst completing selected activities of daily living. Sensor threshold values were used to discern whether users were wearing their orthosis or not. No differences between pressure sensor and accelerometer-based wear time estimations were found. The device's pressure-based wear time estimations were found to have a specificity of 92.7 ± 16.4% and sensitivity of 74.0 ± 41.3%, whilst accelerometer-based wear time estimates had a specificity of 66.1 ± 34.7% and sensitivity of 86.2 ± 8.0%. This study successfully demonstrated the feasibility of monitoring hand orthosis compliance using pressure or acceleration. This device has the potential to provide insight into the effectiveness of both existing and novel orthotics, benefitting both clinical practice and research.