AOT-PA: Action Observation Treatment in Parkinson's Patients

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Unknown status

CT.gov ID

NCT04181918

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson	Behavioral: AOT Behavioral: MI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 26, 2018

Anticipated Primary Completion Date :

Mar 26, 2020

Anticipated Study Completion Date :

Jun 26, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

change in the functional status of the patient [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.
change in Parkinson disease motor symptoms [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.
change in kinematic parameters of the gait (velocity, footing, pace, step length) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Don Carlo Gnocchi	Parma		Italy	43123

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT04181918

Other Study ID Numbers:

AOTPRFDG

First Posted:

Dec 2, 2019

Last Update Posted:

Dec 2, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Don Carlo Gnocchi Onlus

Action Observation Treatment

Motor Imagery

Randomized Controlled Study

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Dec 2, 2019