Parkinson DiseaseTeleAOTPDNCT06814782
Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation in Patients with Parkinson's Disease
A study testing Action Observation Training, Action Observation and Motor Imagery and Exercise in people with Parkinson Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Action Observation Training, Action Observation and Motor Imagery and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- diagnosis of clinically definite PD according to the Movement Disorders Society criteria
- Hoehn and Yahr scale <4
- Montreal Cognitive Assessment, MoCA ≥ 26
- a stable medication regimen for at least 4 weeks.
Who cannot join
- Systemic, psychiatric, or other neurological illnesses influencing motor or functional performance
- a history of substance abuse influencing cognition or compliance
- visual disturbances
- head tremor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Istituto Clinico Humanitas
Rozzano, Milan, 20089
Roberto Gatti, 0282245610, roberto.gatti@hunimed.eu
About this study
Official title: Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation on Mobility, Posture and Brain Plasticity in Patients with Parkinson's Disease
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
Read the detailed description
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).
- Conditions
- Parkinson Disease
- Being tested
- Action Observation Training, Action Observation and Motor Imagery, Exercise
- Keywords
- Action Observation, Motor Imagery, Telerehabilitation, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TrainingOther
Also called AOT, Action Observation Therapy
Action Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements
Action Observation and Motor ImageryOther
Also called AOMI
Action Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements
ExerciseOther
After watching a landscape video, patients will have to perform specific postural and balance exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Action Observation Training |
| 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. Receives: Other: Action Observation and Motor Imagery |
| 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 8 weeks
Functional Independence Measure (FIM)
Functional Independence Measure quantifies autonomy during daily activities
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Mini-BEST Test
Mini-BEST Test investigates dynamic balance control.
Measured: From enrollment to the end follow-up (3 months after end of treatment)
Mini-BEST Test
Mini-BEST Test investigates dynamic balance control.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
10-Meter Walking test
10-Meter Walking test investigates spontaneous and maximum walking speed.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
6-Minute Walking test
6-Minute Walking test investigates walking endurance.
Measured: From enrollment to the end follow-up (3 months after end of treatment)
6-Minute Walking test
6-Minute Walking test investigates walking endurance.
Measured: 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
Measured: 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
Measured: 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
Measured: From end of treatment to the end follow-up (3 months after end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814782
- Sponsor's protocol ID
- CLF24/01
- Other IDs
- PRIN: 2022FABKJ5_2
- Acronym
- TeleAOTPD
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation on Mobility, Posture and Brain Plasticity in Patients with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06814782
- Acronym / sponsor ID
- TeleAOTPD / CLF24/01
- Conditions
- Parkinson Disease
- Keywords
- Action Observation, Motor Imagery, Telerehabilitation, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Action Observation Training Group (AOT) | Experimental | Other: Action Observation TrainingPatients 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. |
| Action Observation and Motor Imagery Group (AOMI) | Experimental | Other: Action Observation and Motor ImageryPatients 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. |
| Control group | Active comparator | Other: ExercisePatients in this group will be exposed to four video presentations showing landscape. Patients will perform the same exercise of AOT groupimmediately after watching. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of clinically definite PD according to the Movement Disorders Society criteria
- Hoehn and Yahr scale <4
- Montreal Cognitive Assessment, MoCA ≥ 26
- a stable medication regimen for at least 4 weeks.
Key exclusion criteria (4 listed)
- Systemic, psychiatric, or other neurological illnesses influencing motor or functional performance
- a history of substance abuse influencing cognition or compliance
- visual disturbances
- head tremor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TrainingAlso: AOT, Action Observation TherapyAction Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements | Other | Action Observation Training Group (AOT) |
| Action Observation and Motor ImageryAlso: AOMIAction Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements | Other | Action Observation and Motor Imagery Group (AOMI) |
| ExerciseAfter watching a landscape video, patients will have to perform specific postural and balance exercises | Other | Control group |
Primary outcome
Timed Up and Go test
Time frame: From enrollment to the end of treatment at 8 weeks
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.
23 secondary outcomes
Timed Up and Go test
Time frame: From enrollment to the end of follow-up at 3 months after end of training
Timed Up and Go test
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
Time frame: From enrollment to the end of treatment at 8 weeks
Movement Disorders Society Unified PD Rating Scale
Time frame: From enrollment to the end follow-up (3 months after end of training)
Movement Disorders Society Unified PD Rating Scale
Time frame: From end of training to the end follow-up (3 months after end of training)
Functional Independence Measure (FIM)
Time frame: From enrollment to the end of treatment at 8 weeks
Functional Independence Measure (FIM)
Time frame: From enrollment to the end follow-up (3 months after end of training)
Functional Independence Measure (FIM)
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)
Time frame: From enrollment to the end of treatment at 8 weeks
Parkinson's disease Questionnaire - 39 items (PDQ-39)
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
Parkinson's disease Questionnaire - 39 items (PDQ-39)
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
Mini-BEST Test
Time frame: From enrollment to the end of treatment at 8 weeks
Mini-BEST Test
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
Mini-BEST Test
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
10-Meter Walking test
Time frame: From enrollment to the end of treatment at 8 weeks
10-Meter Walking test
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
10-Meter Walking test
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
6-Minute Walking test
Time frame: From enrollment to the end of treatment at 8 weeks
6-Minute Walking test
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
6-Minute Walking test
Time frame: From end of treatment to the end of follow-up (3 months after end of treatment)
Freezing of Gait Questionnaire
Time frame: From enrollment to the end of treatment at 8 weeks
Freezing of Gait Questionnaire
Time frame: From enrollment to the end follow-up (3 months after end of treatment)
Freezing of Gait Questionnaire
Time frame: From end of treatment to the end follow-up (3 months after end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Training, Action Observation and Motor Imagery and Exercise in people with Parkinson Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Gatti (0282245610, roberto.gatti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go test (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.