Complex Patients in Rehabilitation Phase Clinical Trial
Official title:
Occupational Therapy in Complex Patients: a Pilot Study
To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient. For this reason, the investigators propose one randomized controlled trial that will compare the group receiving the intervention of OT and the control group, to quantify the level of performance and satisfaction in the activities of interest of the patient, identified through the COPM. The hypothesis is that the benefit may be higher, as clinically relevant, in the group of complex patients treated with the proposed intervention of OT compared to those receiving the usual rehabilitation therapy.
The investigators already implemented an observational pilot study, aimed at defining the
characteristics and needs of the population in question and the OT intervention
characteristics. These information will now be used to implement this randomized controlled
trial, designed to demonstrate the effectiveness of the OT intervention on the basis of
clinically relevant outcome measures.
This study will be set with exploratory purposes, with appropriate high number, which will
allow the investigators to quantify the difference between the two groups in terms of
performance scores derived from the COPM (COPM_p). From the results of this part it will then
depend on the planning for the subsequent study with the correct sample size.
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