Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation in Patients with Parkinson's Disease (TeleAOTPD)

February 3, 2025 updated by: Istituto Clinico Humanitas

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Systemic, psychiatric, or other neurological illnesses influencing motor or functional performance
  • a history of substance abuse influencing cognition or compliance
  • visual disturbances
  • head tremor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Action Observation Training Group (AOT)
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.
Other: Action Observation Training
Action Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements
Other Names:
  • Action Observation Therapy
  • AOT
Experimental: Action Observation and Motor Imagery Group (AOMI)
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.
Other: Action Observation and Motor Imagery
Action Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements
Other Names:
  • AOMI
Active Comparator: Control group
Patients in this group will be exposed to four video presentations showing landscape. Patients will perform the same exercise of AOT groupimmediately after watching.
Other: Exercise
After watching a landscape video, patients will have to perform specific postural and balance exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go test
Time Frame: From enrollment to the end of follow-up at 3 months after end of training
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
Time Frame: From end of training to the end of follow-up at 3 months after end of training
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
Time Frame: From enrollment to the end of treatment at 8 weeks
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
Time Frame: From enrollment to the end follow-up (3 months after end of training)
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
Time Frame: From end of training to the end follow-up (3 months after end of training)
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
Functional Independence Measure quantifies autonomy during daily activities
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 quantifies autonomy during daily activities
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)
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
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)
Time Frame: From enrollment to the end follow-up (3 months after end of treatment)
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)
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) 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
Time Frame: From enrollment to the end of treatment at 8 weeks
Mini-BEST Test investigates dynamic balance control.
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 investigates dynamic balance control.
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)
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
Time Frame: From enrollment to the end of treatment at 8 weeks
10-Meter Walking test investigates spontaneous and maximum walking speed.
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 investigates spontaneous and maximum walking speed.
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)
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
Time Frame: From enrollment to the end of treatment at 8 weeks
6-Minute Walking test investigates walking endurance.
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 investigates walking endurance.
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)
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
Time Frame: From enrollment to the end of treatment at 8 weeks
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
Time Frame: From enrollment to the end follow-up (3 months after end of treatment)
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
Time Frame: From end of treatment to the end follow-up (3 months after end of treatment)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait and gait initiation analysis
Time Frame: From enrollment to the end of treatment at 8 weeks
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
Time Frame: From enrollment 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
Time Frame: From enrollment to the end of treatment at 8 weeks
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
Time Frame: From enrollment to the end follow-up (3 months after end of treatment)
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
Time Frame: From enrollment to the end of treatment at 8 weeks
fMRI investigates brain plasticity and functional reorganization
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLF24/01
  • PRIN: 2022FABKJ5_2 (Other Grant/Funding Number: PNRR - Next Generation EU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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