Action Observation Treatment in Parkinson's Patients (AOT-PA)
Primary Purpose
Parkinson
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AOT
MI
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson focused on measuring Action Observation Treatment, Motor Imagery, Randomized Controlled Study
Eligibility Criteria
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
Sites / Locations
- Fondazione Don Carlo GnocchiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
AOT
MI
Control
Arm Description
This group will observe videos depicting daily actions and afterwards they will execute the seen actions
This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions
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.
Outcomes
Primary Outcome Measures
change in the functional status of the patient
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
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04181918
First Posted
November 18, 2019
Last Updated
November 26, 2019
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT04181918
Brief Title
Action Observation Treatment in Parkinson's Patients
Acronym
AOT-PA
Official Title
Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
March 26, 2020 (Anticipated)
Study Completion Date
June 26, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
Action Observation Treatment, Motor Imagery, Randomized Controlled Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AOT
Arm Type
Experimental
Arm Description
This group will observe videos depicting daily actions and afterwards they will execute the seen actions
Arm Title
MI
Arm Type
Experimental
Arm Description
This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AOT
Intervention Description
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
Intervention Name(s)
MI
Intervention Description
During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output
Primary Outcome Measure Information:
Title
change in the functional status of the patient
Description
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.
Time Frame
Before treatment, within one week after treatment, two months' follow up
Title
change in Parkinson disease motor symptoms
Description
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.
Time Frame
Before treatment, within one week after treatment, two months' follow up
Title
change in kinematic parameters of the gait (velocity, footing, pace, step length)
Description
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.
Time Frame
Before treatment, within one week after treatment, two months' follow up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Buccino
Phone
00390521205683
Ext
0039
Email
neurofis.buccino@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio Rovacchi
Phone
00390521205683
Ext
0039
Email
crovacchi@dongnocchi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Buccino
Organizational Affiliation
Istituto Don Gnocchi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudio Rovacchi
Organizational Affiliation
Istituto Don Gnocchi
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione Don Carlo Gnocchi
City
Parma
ZIP/Postal Code
43123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Grazia Burinato
Phone
00390521205589
Email
mburinato@dongnocchi.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Action Observation Treatment in Parkinson's Patients
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