EXPERIMENTAL PROTOCOL
EXPERIMENTAL PROTOCOL
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The PREDICTOR experimental protocol is stretched along 24 weeks of data acquisition from a pool of 15 patients.
Particularly, patients with stroke from inpatients and outpatients admitted to the Department of Physical Medicine and Rehabilitation, OORR Foggia, are recruited based on inclusion and exclusion criteria, after having provided written informed consent to participate in the study.
All patients who are enrolled already receive a regular rehabilitation treatment established by the rehabilitation multidisciplinary team, whereas the treatments part of this study are delivered as an add-on therapy.
The experimental protocol can be divided into two phases:
Robot Based Rehabilitation (week 1-4)
Hospital and Home based monitoring (week 5-24)
Phase 1 - Robot Based Rehabilitation
Phase 1 - Robot Based Rehabilitation
After an initial clinical assessment, the first 4 weeks consist in:
20 sessions (40 minutes/session, 5 days/week, 4 weeks), occurring at the Department of Physical Medicine and Rehabilitation, OORR Foggia, during which participant undergo, in the following order:
a neurological examination by means of a validated clinical outcomes scale;
the execution of a set of 4 functional tasks - that participants were previously instructed to execute - recorded using the IMU sensors placed at the level of both the paretic and non-paretic shoulder, forearm, and wrist;
a Box & Blocks clinical test;
a robot-based rehabilitation treatment based on Motore, during which data from IMU sensors - placed as explained above - are also acquired;
a continuous, home-based monitoring (24 hours a day) of heart, stress, sleep and motion related data by means of a wristband placed on the paretic side. During the home-based monitoring period, participants carry out their planned activities and their regular life.
Phase 2 - Hospital and Home based monitoring
Phase 2 - Hospital and Home based monitoring
After the first 4 weeks, participants continue with a 5-months follow-up period consisting of two parts:
5 sessions (one per month) during which the 4 evaluation tasks are executed while wearing the IMU sensors with the same configuration explained above. Each task is performed 5 times with a rest period between each repetition, starting with the non-paretic arm to conclude with the paretic one. To guarantee protocol standardization, participants and their carers are trained beforehand on sensors position and exact execution of tasks.
a continuous, home-based monitoring (24 hours a day) of heart, stress, sleep and motion related data by means of a wristband placed on the paretic side.
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