Action Observation Theraphy in Parkinson's Disease

NCT03475355 | Unknown

• 1 other identifier: GR-2011-02349761
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

action observation; parkinson's disease; physical therapy; home-based; neural plasticity; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  4 weeks

Secondary Outcomes (7)

• MDS-UPDRS part II

  4 weeks

• MDS-UPDRS part III

  4 weeks

• PDQ-39

  4 weeks

• Small Coin Rotation Test

  4 weeks

• Small Lock Rotation Test

  4 weeks

Study Arms (6)

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.

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).

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).

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).

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.

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.

Behavioral: Static Picture Observation and Lower Limbs Exercise

Interventions

Live movement observation (Upper Limbs) BEHAVIORAL

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.

EG1

Video Observation (Upper Limbs) BEHAVIORAL

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.

EG2

Live Movement Observation (Lowe Limbs) BEHAVIORAL

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).

EG3

Video Observation (Lower Limbs) BEHAVIORAL

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).

EG4

Static Picture Observation and Upper Limbs Exercise BEHAVIORAL

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.

CG1

Static Picture Observation and Lower Limbs Exercise BEHAVIORAL

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.

CG2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• University of Genova: collaborator
• Università Politecnica delle Marche: collaborator

Study Sites (1)

IRCCS San Camillo Hospital

Venezia, 30126, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 22235059 BACKGROUND

• Pelosin 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.

  PMID: 23392919 BACKGROUND

• Cross 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.

  PMID: 21898675 BACKGROUND

• Alegre 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.

  PMID: 21839480 BACKGROUND

• Buccino 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.

  PMID: 21547952 BACKGROUND

• Pelosin 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.

  PMID: 20453155 BACKGROUND

• Sale 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.

  PMID: 22522432 BACKGROUND

• Alegre 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.

  PMID: 20006544 BACKGROUND

• Franceschini 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.

  PMID: 20414184 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Francesco Infarinato, PhD

  IRCCS San Raffaele

  STUDY DIRECTOR

• Patrizio Sale, PhD

  Univesity of Padua

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Infarinato, PhD

CONTACT

+39 06 5225 3788; francesco.infarinato@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PM&R physician, MD, PhD

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: April 22, 2015
• Primary Completion: July 31, 2018
• Study Completion: October 31, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)