Action Observation Treatment in Parkinson's Patients

NCT ID: NCT04181918

Last Updated: 2019-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2020-06-26

Brief Summary

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The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected.

Detailed Description

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Conditions

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Parkinson

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AOT

This group will observe videos depicting daily actions and afterwards they will execute the seen actions

Group Type EXPERIMENTAL

AOT

Intervention Type BEHAVIORAL

During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.

MI

This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions

Group Type EXPERIMENTAL

MI

Intervention Type BEHAVIORAL

During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output

Control

This group will neither observe nor imagine actions, but simply observe videos with no motor content. Afterwards they will execute the same actions as in AOT and MI.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AOT

During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.

Intervention Type BEHAVIORAL

MI

During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parkinson disease patients on Hoehn and Yahr 3-4

Exclusion Criteria

* Mini-Mental State Examination \< 24
* Fluent aphasic patients
* Apraxia
* Neglect
* major neuropsychiatric disorders
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Buccino

Role: PRINCIPAL_INVESTIGATOR

Istituto Don Gnocchi

Claudio Rovacchi

Role: STUDY_CHAIR

Istituto Don Gnocchi

Locations

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Fondazione Don Carlo Gnocchi

Parma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Buccino

Role: CONTACT

00390521205683 ext. 0039

Claudio Rovacchi

Role: CONTACT

00390521205683 ext. 0039

Facility Contacts

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Maria Grazia Burinato

Role: primary

00390521205589

Other Identifiers

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AOTPRFDG

Identifier Type: -

Identifier Source: org_study_id

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