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

Istituto Clinico Humanitas

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Other: Exercise; Other: Action Observation Training; Other: Action Observation and Motor Imagery

Study type: Interventional

Funder types: Other

Identifiers

NCT06814782

CLF24/01

PRIN: 2022FABKJ5_2 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Action Observation Training Group (AOT)

Experimental group

Description:

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.

Treatment:

Other: Action Observation Training

Action Observation and Motor Imagery Group (AOMI)

Experimental group

Description:

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.

Treatment:

Other: Action Observation and Motor Imagery

Control group

Active Comparator group

Description:

Patients in this group will be exposed to four video presentations showing landscape. Patients will perform the same exercise of AOT groupimmediately after watching.

Treatment:

Other: Exercise