The goal of this clinical trial is to investigate the efficacy on motor and postural tasks of Action Observation Training (AOT) and Action Observation combined with Motor Imagery (AOMI) delivered by telerehabilitation in patients with Parkinson Disease. * The primary endpoint will be mobility measured with the Timed Up and Go (TUG) test (differences before and after telerehabilitation treatment period). * In addition, clinical and functional measures, instrumental analysis of gait and posture, and Magnetic Resonance Imaging (MRI) correlates will be assessed. Participants will be asked to undergo 24 telerehabilitation sessions, cadenced 3 per week, over an 8-week period. In the two experimental groups (AOT and AOMI), each telerehabilitation session will encompass 4 motor tasks, each containing the observation of a video clip immediately followed by the patient's execution or imagination of the same exercises. Patients in the control group will be instructed to perform the same exercises after watching videos showing landscapes
The project is a a single center randomised controlled trial and aims to investigate the efficacy of Action Observation Training (AOT) and Action Observation with Motor Imagery (AOMI) delivered via telerehabilitation for improving motor and postural functions in patients with Parkinson's Disease (PD). Additionally, the study seeks to explore the cortical plasticity induced by AOMI using neuroimaging techniques. The primary outcome measure will be the Timed Up and Go (TUG) test, evaluating changes in mobility before and after the 8-week telerehabilitation intervention. Secondary outcomes include clinical and functional assessments, gait and gait initiation analysis and posture analysis. For gait and gait initiation analysis and posture analysis a sex and age matched healthy subjects cohort will be included. It will be also assessed postural motor resonance in AOT group and control group during action observation at all time point and results compared to sex and age match healthy cohort. Finally last 15 recruited patients of AOMI and control group will undergo fMRI investigation. The study will enroll 60 PD patients, each meeting specific criteria. Participants will be randomly assigned to one of three groups: 1) AOT, 2) AOMI, or 3) a control group. The intervention will consist of 24 telerehabilitation sessions over 8 weeks (3 sessions per week). Each AOT and AOMI session will include four motor tasks, where patients will watch 3-minute video clips, followed by either performing (AOT) or imagining (AOMI) the exercise for 1 minute. Each task will be repeated twice, resulting in a 32-minute session. Exercises will focus on gait and balance, commonly used in PD rehabilitation. The control group will perform similar exercises after watching videos of neutral content, such as landscapes. Assessments will be conducted by blinded evaluators at three time points: baseline (T0), immediately after the intervention period (T8W), and three months post-intervention (T5M).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Action Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements
Action Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements
After watching a landscape video, patients will have to perform specific postural and balance exercises
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Timed Up and Go test
Patients will be instructed to stand up from a chair, walk 3 meters, turn, and return to sit down. The time taken to complete the task will be recorded.
Time frame: From enrollment to the end of treatment at 8 weeks
Timed Up and Go test
Patients will be instructed to stand up from a chair, walk 3 meters, turn, and return to sit down. The time taken to complete the task will be recorded.
Time frame: From enrollment to the end of follow-up at 3 months after end of training
Timed Up and Go test
Patients will be instructed to stand up from a chair, walk 3 meters, turn, and return to sit down. The time taken to complete the task will be recorded.
Time frame: From end of training to the end of follow-up at 3 months after end of training
Movement Disorders Society Unified PD Rating Scale
It's a scale that invenstigates behavioural, motor and functional status of PD patients. The scale is divided in 4 parts and higher score represents worsebehavioural, motor and functional status.
Time frame: From enrollment to the end of treatment at 8 weeks
Movement Disorders Society Unified PD Rating Scale
It's a scale that invenstigates behavioural, motor and functional status of PD patients. The scale is divided in 4 parts and higher score represents worsebehavioural, motor and functional status.
Time frame: From enrollment to the end follow-up (3 months after end of training)
Movement Disorders Society Unified PD Rating Scale
It's a scale that invenstigates behavioural, motor and functional status of PD patients. The scale is divided in 4 parts and higher score represents worsebehavioural, motor and functional status.
Time frame: From end of training to the end follow-up (3 months after end of training)
Functional Independence Measure (FIM)
Functional Independence Measure quantifies autonomy during daily activities
Time frame: From enrollment to the end of treatment at 8 weeks
Functional Independence Measure (FIM)
Functional Independence Measure quantifies autonomy during daily activities
Time frame: From enrollment to the end follow-up (3 months after end of training)
Functional Independence Measure (FIM)
Functional Independence Measure quantifies autonomy during daily activities
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
Parkinson's disease Questionnaire - 39 items (PDQ-39)
Parkinson's disease Questionnaire - 39 items (PDQ-39) investigates quality of life in PD patients.
Time frame: From enrollment to the end of treatment at 8 weeks
Parkinson's disease Questionnaire - 39 items (PDQ-39)
Parkinson's disease Questionnaire - 39 items (PDQ-39) investigates quality of life in PD patients.
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
Parkinson's disease Questionnaire - 39 items (PDQ-39)
Parkinson's disease Questionnaire - 39 items (PDQ-39) investigates quality of life in PD patients.
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
Mini-BEST Test
Mini-BEST Test investigates dynamic balance control.
Time frame: From enrollment to the end of treatment at 8 weeks
Mini-BEST Test
Mini-BEST Test investigates dynamic balance control.
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
Mini-BEST Test
Mini-BEST Test investigates dynamic balance control.
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
10-Meter Walking test
10-Meter Walking test investigates spontaneous and maximum walking speed.
Time frame: From enrollment to the end of treatment at 8 weeks
10-Meter Walking test
10-Meter Walking test investigates spontaneous and maximum walking speed.
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
10-Meter Walking test
10-Meter Walking test investigates spontaneous and maximum walking speed.
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
6-Minute Walking test
6-Minute Walking test investigates walking endurance.
Time frame: From enrollment to the end of treatment at 8 weeks
6-Minute Walking test
6-Minute Walking test investigates walking endurance.
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
6-Minute Walking test
6-Minute Walking test investigates walking endurance.
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
Freezing of Gait Questionnaire
Freezing of Gait Questionnaire investigates freezing of gait episodes during daily life
Time frame: From enrollment to the end of treatment at 8 weeks
Freezing of Gait Questionnaire
Freezing of Gait Questionnaire investigates freezing of gait episodes during daily life
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
Freezing of Gait Questionnaire
Freezing of Gait Questionnaire investigates freezing of gait episodes during daily life
Time frame: From end of treatment to the end follow-up (3 months after end of treatment)
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