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PARKINSON’S DISEASE TRIALS
For Parkinson’s disease, four phases of experiments are envisaged along the project time schedule. At the initial stage, a pre-prototype sensors setting for daily monitoring will be used, to allow testing the system idea and familiarize the clinicians with the use of wearable sensors. Initially, the system will be tested on the clinicians themselves and will allow the technical partners to collect sensor data and deploy the initial set of algorithms for symptoms detection and quantification. During this phase the Consortium envisages to identify issues that might obstruct the system usage, which will be taken into account in the design of the first wearable system prototype to be used on patients. The total number of persons involved in this phase is 20 (10 in UoI, 10 in UNAV), and this phase is expected to be completed by end of April 2009.
The second phase will introduce this initial daily monitoring prototype to the patients, and will focus on collecting data from real patient during on and off states under close medical supervision. At the same time the third patient prototype will be prepared incorporating the administration of any risen issues during the second experiments phase, and all system’s intelligence will be adapted to the real patient data. Ten (10) patients (5 in UoI and 5 in UNAV) will be involved in this phase and the recordings should be collected from May to July 2009.
The third phase will introduce the PERFORM system, including the daily monitoring, the nocturnal monitoring, the test devices to the patient and will be used to evaluate the system’s performance in detecting and quantifying patient symptoms in order to verify system developed algorithms. Twenty four (24) patients will be involved in this stage (12 in UoI and 12 in UNAV). Each patient will be continuously monitored at home for a week and the Recordings should be collected from October 2009 until March 2010.
After the finalization of this phase, the integrated and final PERFORM system will be introduced to the final group of patients for the final system evaluation. The concept of the fourth phase is to monitor a larger number of patient’s status as they move around freely doing their everyday activities, and to evaluate the final PERFORM system. The Italian Pilot will involve twenty (20) patients for continuous recordings and spontaneous observation for a week at home. This phase will be completed by the end of 2010.
AMYOTROPHIC LATERAL SCLEROSIS TRIALS
In the case of ALS only one set of experiments is envisaged and the objective of this study is to evaluate the PERFORM system usage for the ALS patients. Five (5) patients with advanced amyotrophic lateral sclerosis (ALS) and respiratory insufficiency will be assessed. We are going to test respiratory system by using a spirometer and saturation measurements at night. On the other hand we are going to test their ability to lift their feet and their hand when seated. What we want to test by introducing this group is a smaller group of functionalities that are crucial to other neurodegenerative diseases (such as respiration).
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