Digital Tools for Assessment of Motor Functions and Falls in ALS

This system is composed of a Study Tablet running custom fall detection and reporting software and PAMSys sensors. PAMSys provides clinical-grade physical activity monitoring, storing the raw accelerometer data that can be used for analyzing activity parameters such as those listed in Table 3. Sensor data will be downloaded manually upon receipt of the study device by Biosensics, the study sponsor. Sensors can be worn during all activities including while showering and sleeping. The rated battery life is 3-6 months for the fall sensor, and 4 weeks for the activity sensors. This system is not classified as a medical device. Reports of sensor use, step number, battery level, and memory availability are sent hourly to a secured and HIPAA compliant back-end server provided by BioSensics. The Study Tablet also contains modules for performing speech, handwriting, and pattern tracing tasks.

"These assessments occur at each study visit. After equipping the subject with 3 activity sensors (1 on pendant around neck and 2 on wrists).~* 10-meter walk task (5 minutes) - The subject starts from a standing position and walks a length of 10 meters. The best time of three trials is used.~* Timed Up and Go (TUG) test (5 minutes) - Subjects stand, walk to a marker on the floor 3 meters ahead, turn around the marker, walk back to the chair, and sit. The best time of three trials is used.~* Handwriting Assessment Battery (HAB) (15 minutes) \[Faddy2008\] - The subject is seated at a table with a pencil and paper and performs a series of writing tasks.~* Speech Assessment Battery (SAB)(10 minutes) - The participant will perform a set of audio recordings using the study tablet while sitting in a quiet room."