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Clinical Trial Summary

The main objective of this project is to evaluate the effectiveness of Observation of Action (Action Observation, AO) both in increasing the speed of movement of the upper limbs, agility and locomotion, and in improving the activities and quality of life in people with Parkinson's disease (PD) during a 4-6 month follow-up. The second objective is to evaluate the feasibility and effectiveness of a tele-rehabilitation protocol using home-based AO therapy. The telecommunication technology will provide a complete training through a low-cost software run on a touch-screen device, which will show the actions to be imitated several times by people with PD. This project will be the first attempt to implement AO-based treatment at home and, if successful, will be highly translational to clinical practice thanks to the advanced development and broad accessibility of information technology and telecommunications in our country. Furthermore, continuous exercise will reduce the risks of complications and the frequency of hospital admissions, thus reducing costs for the National Health System.


Clinical Trial Description

The main objective of this project is to evaluate the effectiveness of Observation of Action (AO) both in increasing the speed of movement of the upper limbs, agility and locomotion, and in improving activities and quality of life in people with Parkinson's disease (PD) during a 4-6 month follow-up. The second objective is to evaluate the feasibility and effectiveness of a tele-rehabilitation protocol using home-based AO therapy. The telecommunication technology will provide a complete training through a low-cost software run on a touch-screen device, which will show the actions to be imitated several times by people with PD. This project will be the first attempt to implement AO-based treatment at home and, if successful, will be highly translational to clinical practice thanks to the advanced development and broad accessibility of information technology and telecommunications in our country. Furthermore, continuous exercise will reduce the risks of complications and the frequency of hospital admissions, thus reducing costs for the National Health System.

Parkinson's disease (PD) should impose a growing social and economic burden on our country. In fact, even with optimal medical management, people with PD experience a worsening of mobility and independence in daily activities, with a consequent reduction in quality of life. In the last ten years there has been a growing demand to consider rehabilitation as an essential adjunct to pharmacological treatment. However, the reference rates for physiotherapy for people with Parkinson's disease have been historically low, both because of poor compliance by patients with the therapies of the movement and because of the scarce availability of physiotherapy services. Action Observation Therapy (AO) has recently been described as an effective strategy in stroke rehabilitation (Sale 2011, 2012), since it can shape the reorganization of the neural circuit, promote neural plasticity and motor learning. . The purpose of this study is to verify the efficacy of AO therapy on PD-related disability and to verify the feasibility of a home-based AO protocol.

The first specific objective of this project is to evaluate the effectiveness of action observation as an additional rehabilitative tool to improve upper limb function in terms of bradykinesia and dexterity and to investigate the stability of treatment effects after 4 / 6 months of follow-up regarding functional improvement and quality of life (QoL). The second specific objective of this project is to evaluate the effectiveness of the observation of the action as an additional rehabilitative tool to improve the balance , gait and, consequently, to reduce falls, and to investigate the stability of treatment effects at 4/6 months of follow-up in terms of functional improvement and quality of life (QoL). The third objective is to evaluate the feasibility and effectiveness of a home telerehabilitation protocol (TR) based on AO therapy to improve dexterity and ambulation in people with Parkinson's disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03475355
Study type Interventional
Source IRCCS San Camillo, Venezia, Italy
Contact Francesco Infarinato, PhD
Phone +39 06 5225 3788
Email francesco.infarinato@sanraffaele.it
Status Recruiting
Phase N/A
Start date April 22, 2015
Completion date October 31, 2018

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