Parkinson DiseaseACTIONPARKNCT03475355
Action Observation Theraphy in Parkinson's Disease
A study testing Live movement observation (Upper Limbs), Video Observation (Upper Limbs) and Live Movement Observation (Lowe Limbs) in people with Parkinson Disease, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Live movement observation (Upper Limbs), Video Observation (Upper Limbs) and Live Movement Observation (Lowe Limbs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2015to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- comorbidity with other neurological disorders;
- heart or orthopedic problems;
- Chronic alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Camillo Hospital
Venezia, 30126
Giovanni Gentile, MSc, 3282438545, giovanni.gentile@ospedalesancamillo.net
Giovanni Gentile, MSc
About this study
Official title: Action Observation Therapy: a Chance for Parkinson's Disease Patients of Improving Mobility Through a Home-based Training
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Live movement observation (Upper Limbs), Video Observation (Upper Limbs), Live Movement Observation (Lowe Limbs), Video Observation (Lower Limbs), Static Picture Observation and Upper Limbs Exercise
- Keywords
- action observation, parkinson's disease, physical therapy, home-based, neural plasticity, telerehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live movement observation (Upper Limbs)Behavioural
All participants will be subjected to two 15-minute sessions per day of the Live movement observation of the upper limbs. The activities of the upper limbs will be based on some relevant activities of daily life such as drinking from a glass, combing, opening a box or eating an apple. The tasks will be both unimanual and bimanual.
Every day, before starting the physical training, the patient will be asked to look carefully at the therapist who shows 20 different daily routine activities (actions) performed with the upper limb.
Video Observation (Upper Limbs)Behavioural
All participants will be subjected to two 15-minute sessions per day of the video observation of upper limbs movements. The activities of the upper limbs will be based on some relevant activities of daily life such as drinking from a glass, combing, opening a box or eating an apple. The tasks will be both unimanual and bimanual.
Every day, before starting the physical training, the patient will be asked to carefully watch a video showing 20 different daily routine activities (actions) performed with the upper limb.
Live Movement Observation (Lowe Limbs)Behavioural
All participants will be subjected to two 15-minute sessions per day of the Live movement observation of the lower limbs. Tasks to avoid freezing will be based on strategies such as touching the thigh, taking side or back steps, counting out loud while walking.
Every day, before starting the physical training, the patient will be asked to carefully watch the therapist who will show 20 different movement strategies to avoid episodes of freezing the pace (FOG).
Video Observation (Lower Limbs)Behavioural
All participants will be subjected to two 15-minute sessions per day of the video observation of lower limbs movements. Tasks to avoid freezing will be based on strategies such as touching the thigh, taking side or back steps, counting out loud while walking. Every day, before starting the physical training, the patient will be asked to carefully watch a video that will show 20 different movement strategies to avoid episodes of freezing the pace (FOG).
Static Picture Observation and Upper Limbs ExerciseBehavioural
Participants will watch 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. The patient will be presented a sequence of images for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, they will be displayed together with an intrusive image (intruder) that the patient you will be asked to identify so that your attention span can be controlled in real time. Participants will then be invited to perform limb movements as far as possible for 2 minutes according to a standard sequence involving joint mobilisations of upper limbs, and simulating that performed by the experimental groups.
Static Picture Observation and Lower Limbs ExerciseBehavioural
Participants will watch 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. The patient will be presented a sequence of images for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, they will be displayed together with an intrusive image (intruder) that the patient you will be asked to identify so that your attention span can be controlled in real time. Participants will then be invited to perform limb movements as far as possible for 2 minutes according to a standard sequence involving joint mobilisations of lower limbs, and simulating that performed by the experimental groups.
| Study group | Role | What they receive |
|---|---|---|
| EG1 | Experimental | 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. Receives: Behavioral: Live movement observation (Upper Limbs) |
| EG2 | Experimental | 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). Receives: Behavioral: Video Observation (Upper Limbs) |
| EG3 | Experimental | 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). Receives: Behavioral: Live Movement Observation (Lowe Limbs) |
| EG4 | Experimental | 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). Receives: Behavioral: Video Observation (Lower Limbs) |
| CG1 | Active comparator | 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. Receives: Behavioral: Static Picture Observation and Upper Limbs Exercise |
| CG2 | Active comparator | 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. Receives: Behavioral: Static Picture Observation and Lower Limbs Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block test
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.
Measured: 4 weeks
Nine Hole Peg Test
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
Measured: 4 weeks
Secondary outcomes (7)
MDS-UPDRS part II
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.
Measured: 4 weeks
MDS-UPDRS part III
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.
Measured: 4 weeks
PDQ-39
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.
Measured: 4 weeks
Small Coin Rotation Test
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.
Measured: 4 weeks
Small Lock Rotation Test
Measured: 4 weeks
Clinical Global Impression Scale
The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies
Measured: 4 weeks
3D Movement Analysis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start22 Apr 2015
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova, Università Politecnica delle Marche
- Responsible party
- Principal investigator, Patrizio Sale, University of Padova
- Investigators
- Francesco Infarinato, PhD, Study director, IRCCS San RaffaelePatrizio Sale, PhD, Principal investigator, Univesity of Padua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475355
- Sponsor's protocol ID
- GR-2011-02349761
- Acronym
- ACTIONPARK
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
PubMed 22235059Pelosin E, Bove M, Ruggeri P, Avanzino L, Abbruzzese G. Reduction of bradykinesia of finger movements by a single session of action observation in Parkinson disease. Neurorehabil Neural Repair. 2013 Jul-Aug;27(6):552-60. doi: 10.1177/1545968312471905. Epub 2013 Feb 7.
PubMed 23392919Cross ES, Liepelt R, Hamilton AF, Parkinson J, Ramsey R, Stadler W, Prinz W. Robotic movement preferentially engages the action observation network. Hum Brain Mapp. 2012 Sep;33(9):2238-54. doi: 10.1002/hbm.21361. Epub 2011 Sep 6.
PubMed 21898675Alegre M, Guridi J, Artieda J. The mirror system, theory of mind and Parkinson's disease. J Neurol Sci. 2011 Nov 15;310(1-2):194-6. doi: 10.1016/j.jns.2011.07.030. Epub 2011 Aug 11.
PubMed 21839480Buccino G, Gatti R, Giusti MC, Negrotti A, Rossi A, Calzetti S, Cappa SF. Action observation treatment improves autonomy in daily activities in Parkinson's disease patients: results from a pilot study. Mov Disord. 2011 Aug 15;26(10):1963-4. doi: 10.1002/mds.23745. Epub 2011 May 5. No abstract available.
PubMed 21547952Pelosin E, Avanzino L, Bove M, Stramesi P, Nieuwboer A, Abbruzzese G. Action observation improves freezing of gait in patients with Parkinson's disease. Neurorehabil Neural Repair. 2010 Oct;24(8):746-52. doi: 10.1177/1545968310368685. Epub 2010 May 7.
PubMed 20453155Sale P, Franceschini M. Action observation and mirror neuron network: a tool for motor stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Jun;48(2):313-8. Epub 2012 Apr 20.
PubMed 22522432Alegre M, Rodriguez-Oroz MC, Valencia M, Perez-Alcazar M, Guridi J, Iriarte J, Obeso JA, Artieda J. Changes in subthalamic activity during movement observation in Parkinson's disease: is the mirror system mirrored in the basal ganglia? Clin Neurophysiol. 2010 Mar;121(3):414-25. doi: 10.1016/j.clinph.2009.11.013. Epub 2009 Dec 16.
PubMed 20006544Franceschini M, Agosti M, Cantagallo A, Sale P, Mancuso M, Buccino G. Mirror neurons: action observation treatment as a tool in stroke rehabilitation. Eur J Phys Rehabil Med. 2010 Dec;46(4):517-23. Epub 2010 Apr 23.
PubMed 20414184
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation Therapy: a Chance for Parkinson's Disease Patients of Improving Mobility Through a Home-based Training
- ClinicalTrials.gov ID
- NCT03475355
- Acronym / sponsor ID
- ACTIONPARK / GR-2011-02349761
- Conditions
- Parkinson Disease
- Keywords
- action observation, parkinson's disease, physical therapy, home-based, neural plasticity, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- University of Genova, Università Politecnica delle Marche
- Study start
- 22 Apr 2015 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EG1 | Experimental | Behavioral: Live movement observation (Upper Limbs)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. |
| EG2 | Experimental | Behavioral: Video Observation (Upper Limbs)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). |
| EG3 | Experimental | Behavioral: Live Movement Observation (Lowe Limbs)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). |
| EG4 | Experimental | Behavioral: Video Observation (Lower Limbs)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). |
| CG1 | Active comparator | Behavioral: Static Picture Observation and Upper Limbs ExerciseParticipants 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. |
| CG2 | Active comparator | Behavioral: Static Picture Observation and Lower Limbs ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- comorbidity with other neurological disorders;
- heart or orthopedic problems;
- Chronic alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live movement observation (Upper Limbs)All participants will be subjected to two 15-minute sessions per day of the Live movement observation of the upper limbs. The activities of the upper limbs will be based on some relevant activities of daily life such as drinking from a glass, combing, opening a box or eating an apple. The tasks will be both unimanual and bimanual. Every day, before starting the physical training, the patient will be asked to look carefully at the therapist who shows 20 different daily routine activities (actions) performed with the upper limb. | Behavioural | EG1 |
| Video Observation (Upper Limbs)All participants will be subjected to two 15-minute sessions per day of the video observation of upper limbs movements. The activities of the upper limbs will be based on some relevant activities of daily life such as drinking from a glass, combing, opening a box or eating an apple. The tasks will be both unimanual and bimanual. Every day, before starting the physical training, the patient will be asked to carefully watch a video showing 20 different daily routine activities (actions) performed with the upper limb. | Behavioural | EG2 |
| Live Movement Observation (Lowe Limbs)All participants will be subjected to two 15-minute sessions per day of the Live movement observation of the lower limbs. Tasks to avoid freezing will be based on strategies such as touching the thigh, taking side or back steps, counting out loud while walking. Every day, before starting the physical training, the patient will be asked to carefully watch the therapist who will show 20 different movement strategies to avoid episodes of freezing the pace (FOG). | Behavioural | EG3 |
| Video Observation (Lower Limbs)All participants will be subjected to two 15-minute sessions per day of the video observation of lower limbs movements. Tasks to avoid freezing will be based on strategies such as touching the thigh, taking side or back steps, counting out loud while walking. Every day, before starting the physical training, the patient will be asked to carefully watch a video that will show 20 different movement strategies to avoid episodes of freezing the pace (FOG). | Behavioural | EG4 |
| Static Picture Observation and Upper Limbs ExerciseParticipants will watch 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. The patient will be presented a sequence of images for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, they will be displayed together with an intrusive image (intruder) that the patient you will be asked to identify so that your attention span can be controlled in real time. Participants will then be invited to perform limb movements as far as possible for 2 minutes according to a standard sequence involving joint mobilisations of upper limbs, and simulating that performed by the experimental groups. | Behavioural | CG1 |
| Static Picture Observation and Lower Limbs ExerciseParticipants will watch 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. The patient will be presented a sequence of images for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, they will be displayed together with an intrusive image (intruder) that the patient you will be asked to identify so that your attention span can be controlled in real time. Participants will then be invited to perform limb movements as far as possible for 2 minutes according to a standard sequence involving joint mobilisations of lower limbs, and simulating that performed by the experimental groups. | Behavioural | CG2 |
Primary outcome
Box and Block test
Time frame: 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.
Nine Hole Peg Test
Time frame: 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
7 secondary outcomes
MDS-UPDRS part II
Time frame: 4 weeks
MDS-UPDRS part III
Time frame: 4 weeks
PDQ-39
Time frame: 4 weeks
Small Coin Rotation Test
Time frame: 4 weeks
Small Lock Rotation Test
Time frame: 4 weeks
Clinical Global Impression Scale
Time frame: 4 weeks
3D Movement Analysis
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Background: PubMed 22235059Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
- Background: PubMed 23392919Pelosin E, Bove M, Ruggeri P, Avanzino L, Abbruzzese G. Reduction of bradykinesia of finger movements by a single session of action observation in Parkinson disease. Neurorehabil Neural Repair. 2013 Jul-Aug;27(6):552-60. doi: 10.1177/1545968312471905. Epub 2013 Feb 7.
- Background: PubMed 21898675Cross ES, Liepelt R, Hamilton AF, Parkinson J, Ramsey R, Stadler W, Prinz W. Robotic movement preferentially engages the action observation network. Hum Brain Mapp. 2012 Sep;33(9):2238-54. doi: 10.1002/hbm.21361. Epub 2011 Sep 6.
- Background: PubMed 21839480Alegre M, Guridi J, Artieda J. The mirror system, theory of mind and Parkinson's disease. J Neurol Sci. 2011 Nov 15;310(1-2):194-6. doi: 10.1016/j.jns.2011.07.030. Epub 2011 Aug 11.
- Background: PubMed 21547952Buccino G, Gatti R, Giusti MC, Negrotti A, Rossi A, Calzetti S, Cappa SF. Action observation treatment improves autonomy in daily activities in Parkinson's disease patients: results from a pilot study. Mov Disord. 2011 Aug 15;26(10):1963-4. doi: 10.1002/mds.23745. Epub 2011 May 5. No abstract available.
- Background: PubMed 20453155Pelosin E, Avanzino L, Bove M, Stramesi P, Nieuwboer A, Abbruzzese G. Action observation improves freezing of gait in patients with Parkinson's disease. Neurorehabil Neural Repair. 2010 Oct;24(8):746-52. doi: 10.1177/1545968310368685. Epub 2010 May 7.
- Background: PubMed 22522432Sale P, Franceschini M. Action observation and mirror neuron network: a tool for motor stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Jun;48(2):313-8. Epub 2012 Apr 20.
- Background: PubMed 20006544Alegre M, Rodriguez-Oroz MC, Valencia M, Perez-Alcazar M, Guridi J, Iriarte J, Obeso JA, Artieda J. Changes in subthalamic activity during movement observation in Parkinson's disease: is the mirror system mirrored in the basal ganglia? Clin Neurophysiol. 2010 Mar;121(3):414-25. doi: 10.1016/j.clinph.2009.11.013. Epub 2009 Dec 16.
- Background: PubMed 20414184Franceschini M, Agosti M, Cantagallo A, Sale P, Mancuso M, Buccino G. Mirror neurons: action observation treatment as a tool in stroke rehabilitation. Eur J Phys Rehabil Med. 2010 Dec;46(4):517-23. Epub 2010 Apr 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Infarinato, PhD study director
IRCCS San Raffaele
Patrizio Sale, PhD principal investigator
Univesity of Padua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live movement observation (Upper Limbs), Video Observation (Upper Limbs) and Live Movement Observation (Lowe Limbs) in people with Parkinson Disease, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Infarinato, PhD (+39 06 5225 3788, francesco.infarinato@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block test (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475355, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.