Action Observation Theraphy in Parkinson's Disease
- Conditions
- Parkinson Disease
- Registration Number
- NCT03475355
- Lead Sponsor
- IRCCS San Camillo, Venezia, Italy
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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.
- comorbidity with other neurological disorders;
- heart or orthopedic problems;
- Chronic alcohol abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Nine Hole Peg Test 4 weeks The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible
Box and Block test 4 weeks The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.
- Secondary Outcome Measures
Name Time Method MDS-UPDRS part II 4 weeks 13 items scale focusing on the self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food. Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
PDQ-39 4 weeks PDQ-39
There are 39 questions in the long form Parkinson's Disease Questionnaire, with 8 discrete scales: mobility (10 items); activities of daily living (6 items); emotional well-being (6 items); stigma (4 items); social support (3 items); cognitions (4 items); communication (3 items); bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (likert Scale): never/occasionally/sometimes/often/always or cannot do at all.Clinical Global Impression Scale 4 weeks The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies
MDS-UPDRS part III 4 weeks 18 items scale based on clinician-scored monitored motor evaluation. Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Small Lock Rotation Test 4 weeks Small Coin Rotation Test 4 weeks The coin rotation task (CRT) is a simple, convenient, and cost-effective measure of psychomotor processing speed. In the CRT, participants rotate a coin through serial 180-degree turns using the thumb, index, and middle fingers for 10 seconds.
3D Movement Analysis 4 weeks
Trial Locations
- Locations (1)
IRCCS San Camillo Hospital
🇮🇹Venezia, Italy
IRCCS San Camillo Hospital🇮🇹Venezia, ItalyGiovanni Gentile, MScPrincipal Investigator