Action Observation Treatment in Parkinson's Patients (AOT-PA)

November 26, 2019 updated by: Fondazione Don Carlo Gnocchi Onlus

Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43123
        • Recruiting
        • Fondazione Don Carlo Gnocchi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AOT
This group will observe videos depicting daily actions and afterwards they will execute the seen actions
Behavioral: AOT
During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.
EXPERIMENTAL: MI
This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions
Behavioral: MI
During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the functional status of the patient
Time Frame: Before treatment, within one week after treatment, two months' follow up
to assess the change in the functional status of the patient, the Functional Independence Measure (FIM) will be used. FIM consists in a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence), and it can detect changes in the patient's status in 18 categories, focusing on motor and cognitive function. Functional patients' status will assess before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
Before treatment, within one week after treatment, two months' follow up
change in Parkinson disease motor symptoms
Time Frame: Before treatment, within one week after treatment, two months' follow up
to assess the change in motor status of the patient, the Unified Parkinson's Disease Rating Scale (UPDRS) will be used, and it consists in a 5-point scale (0 = no signs; 4 = severe). UPDRS will be administered before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
Before treatment, within one week after treatment, two months' follow up
change in kinematic parameters of the gait (velocity, footing, pace, step length)
Time Frame: Before treatment, within one week after treatment, two months' follow up
to assess the change of patient's gait parameters, the kinematic analysis will be used (i.e. gait analysis). The gait analysis allows to detect fine-grain changes in kinematic parameters of the movement, through a non-invasive methodology. Gait analysis will be performed before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
Before treatment, within one week after treatment, two months' follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Giovanni Buccino, Istituto Don Gnocchi
  • Study Chair: Claudio Rovacchi, Istituto Don Gnocchi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 26, 2018

Primary Completion (ANTICIPATED)

March 26, 2020

Study Completion (ANTICIPATED)

June 26, 2020

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (ACTUAL)

December 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOTPRFDG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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