Action Observation Theraphy in Parkinson's Disease (ACTIONPARK)

IRCCS San Camillo, Venezia, Italy

Status: Unknown

Conditions: Parkinson Disease

Treatments: Behavioral: Live Movement Observation (Lowe Limbs); Behavioral: Video Observation (Upper Limbs); Behavioral: Static Picture Observation and Lower Limbs Exercise; Behavioral: Video Observation (Lower Limbs); Behavioral: Live movement observation (Upper Limbs); Behavioral: Static Picture Observation and Upper Limbs Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03475355

GR-2011-02349761

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic PD according to the UK BRAIN BANK criteria;
• Age between 18 and 80 years;
• Able to walk 25 meters without help or with minimal assistance and sufficient strength to remain standing for at least 20 minutes without assistance for patient report; Stability of drug therapy for Parkinson's disease for at least 4 weeks before the start of the study;
• Mini-Mental State Examination> 25/30;
• HAM-D (Hamilton Depression Scale) <17.

Exclusion criteria

• comorbidity with other neurological disorders;
• heart or orthopedic problems;
• Chronic alcohol abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 6 patient groups

EG1

Experimental group

Description:

Each patient will be instructed to carefully observe the finalized movement of the upper limb of an experimenter seated in front (the experimenter's left hand is right in front of the patient's right hand), without moving or imagining the movement.

Treatment:

Behavioral: Live movement observation (Upper Limbs)

EG2

Experimental group

Description:

Each patient will be instructed to look at a computer screen that is in front of him that will show a daily routine task (actions).

Treatment:

Behavioral: Video Observation (Upper Limbs)

EG3

Experimental group

Description:

Each patient will be instructed to carefully observe the finalized movement performed by an experimenter standing in front of him (the examiner's left leg will be in front of the patient's right leg).

Treatment:

Behavioral: Live Movement Observation (Lowe Limbs)

EG4

Experimental group

Description:

Each patient will be instructed to look at a computer screen that is in front of him that will show a daily routine task (actions).

Treatment:

Behavioral: Video Observation (Lower Limbs)

CG1

Active Comparator group

Description:

Participants will be shown for 3 minutes 5 static images that expose objects, none will represent animals or people. The participant's attention will be kept high through a cognitive task. For each CGail patient condition a sequence of images will be presented for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, will be displayed together with an intrusive image (intruder) that the patient will be asked to identify so that his attention span can be controlled in real time. Participants will then be invited to perform movements of the limbs as far as possible for 2 minutes according to a standard sequence that involves articular mobilizations of upper limbs and simulates that performed by the experimental groups.

Treatment:

Behavioral: Static Picture Observation and Upper Limbs Exercise

CG2

Active Comparator group

Description:

Participants will be shown for 3 minutes 5 static images that expose objects, none will represent animals or people. The participant's attention will be kept high through a cognitive task. For each CGail patient condition a sequence of images will be presented for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, will be displayed together with an intrusive image (intruder) that the patient will be asked to identify so that his attention span can be controlled in real time. Participants will then be invited to perform movements of the limbs as far as possible for 2 minutes according to a standard sequence that involves articular mobilizations of lower limbs and simulates that performed by the experimental groups.

Treatment:

Behavioral: Static Picture Observation and Lower Limbs Exercise