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Action Observation Theraphy in Parkinson's Disease

Action Observation Therapy: a Chance for Parkinson's Disease Patients of Improving Mobility Through a Home-based Training

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03475355
Acronym
ACTIONPARK
Enrollment
90
Registered
2018-03-23
Start date
2015-04-22
Completion date
2018-10-31
Last updated
2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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.

Interventions

BEHAVIORALLive 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.

BEHAVIORALVideo 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.

BEHAVIORALLive 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).

BEHAVIORALVideo 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).

BEHAVIORALStatic Picture Observation and Upper Limbs Exercise

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.

BEHAVIORALStatic Picture Observation and Lower Limbs Exercise

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.

Sponsors

University of Genova
CollaboratorOTHER
Università Politecnica delle Marche
CollaboratorOTHER
IRCCS San Camillo, Venezia, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Box and Block test4 weeksThe 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 Test4 weeksThe 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

Secondary

MeasureTime frameDescription
PDQ-394 weeksPDQ-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.
Small Coin Rotation Test4 weeksThe 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.
MDS-UPDRS part II4 weeks13 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.
Clinical Global Impression Scale4 weeksThe Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies
3D Movement Analysis4 weeks
Small Lock Rotation Test4 weeks
MDS-UPDRS part III4 weeks18 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.

Countries

Italy

Contacts

Primary ContactFrancesco Infarinato, PhD
francesco.infarinato@sanraffaele.it+39 06 5225 3788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026