Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06814782

Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation 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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Action Observation training

Other

Action Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements

Other names: AOT, Action Observation Therapy

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

Other names: AOMI

Exercise

Other

After watching a landscape video, patients will have to perform specific postural and balance exercises

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Functional Independence Measure (FIM)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Functional Independence Measure quantifies autonomy during daily activities

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. Mini-BEST Test

    Time frame: From enrollment to the end of treatment at 8 weeks

    Mini-BEST Test investigates dynamic balance control.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 6-Minute Walking test

    Time frame: From enrollment to the end of treatment at 8 weeks

    6-Minute Walking test investigates walking endurance.

  19. 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.

  20. 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.

  21. 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

  22. 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

  23. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Functional Magnetic Resonance Imaging

    Time frame: From enrollment to the end of treatment at 8 weeks

    fMRI investigates brain plasticity and functional reorganization

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Gatti

CONTACT

[email protected]

0282245610

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation on Mobility, Posture and Brain Plasticity in Patients with Parkinson's Disease

Acronym: TeleAOTPD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.