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| ID | Type | Description | Link |
|---|---|---|---|
| PRIN: 2022FABKJ5_2 | Other Grant/Funding Number | PNRR - Next Generation EU |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Action Observation Training Group (AOT) | Experimental | Patients in this group will be exposed to four video presentations showing movements with different degrees of focal vs. postural components. The patients will imitate immediately after watching. |
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| Action Observation and Motor Imagery Group (AOMI) | Experimental | Patients in this group will be exposed to four video presentations showing movements with different degrees of focal vs. postural components. The patients will mentally rehearse what they saw in the videos immediately after watching. |
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| Control group | Active Comparator | Patients in this group will be exposed to four video presentations showing landscape. Patients will perform the same exercise of AOT groupimmediately after watching. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Action Observation Training | Other | Action Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of follow-up at 3 months after end of training |
| Timed Up and Go test |
| Measure | Description | Time Frame |
|---|---|---|
| Gait and gait initiation analysis | Gait and gait initiation analysis measure the kinematic parameters of gait and the Anticipatory Postural Adjustments | From enrollment to the end of treatment at 8 weeks |
| Gait and gait initiation analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Gatti | Contact | 0282245610 | roberto.gatti@hunimed.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Rozzano | Milan | 20089 | Italy |
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| Action Observation and Motor Imagery | Other | Action Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements |
|
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| Exercise | Other | After watching a landscape video, patients will have to perform specific postural and balance exercises |
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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. |
| 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. | 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. | 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. | 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 | From enrollment to the end of treatment at 8 weeks |
| Functional Independence Measure (FIM) | Functional Independence Measure quantifies autonomy during daily activities | 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 | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 8 weeks |
| Mini-BEST Test | Mini-BEST Test investigates dynamic balance control. | From enrollment to the end follow-up (3 months after end of treatment) |
| Mini-BEST Test | Mini-BEST Test investigates dynamic balance control. | 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. | From enrollment to the end of treatment at 8 weeks |
| 10-Meter Walking test | 10-Meter Walking test investigates spontaneous and maximum walking speed. | 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. | 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. | From enrollment to the end of treatment at 8 weeks |
| 6-Minute Walking test | 6-Minute Walking test investigates walking endurance. | From enrollment to the end follow-up (3 months after end of treatment) |
| 6-Minute Walking test | 6-Minute Walking test investigates walking endurance. | 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 | 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 | 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 | From end of treatment to the end follow-up (3 months after end of treatment) |
Gait and gait initiation analysis measure the kinematic parameters of gait and the Anticipatory Postural Adjustments
| From enrollment to the end follow-up (3 months after end of treatment) |
| Posture analysis | Change of postural motor resonance of the mirror neuron system during Action Observation through H-reflex assessment | From enrollment to the end of treatment at 8 weeks |
| Posture analysis | Change of postural motor resonance of the mirror neuron system during Action Observation through H-reflex assessment | From enrollment to the end follow-up (3 months after end of treatment) |
| Functional Magnetic Resonance Imaging | fMRI investigates brain plasticity and functional reorganization | From enrollment to the end of treatment at 8 weeks |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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