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

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06814782
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

* 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 Timeline

• Study First Submitted: 2025-01-10
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Study Start: 2025-03-01
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Timed Up and Go test	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 Outcome Measures

Name	Time	Method
Movement Disorders Society Unified PD Rating Scale	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.
Timed Up and Go test	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.
Mini-BEST Test	From end of treatment to the end of follow-up (3 months after end of treatment)	Mini-BEST Test investigates dynamic balance control.
6-Minute Walking test	From end of treatment to the end of follow-up (3 months after end of treatment)	6-Minute Walking test investigates walking endurance.
Functional Independence Measure (FIM)	From end of treatment to the end of follow-up (3 months after end of treatment)	Functional Independence Measure quantifies autonomy during daily activities
Parkinson's disease Questionnaire - 39 items (PDQ-39)	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.
10-Meter Walking test	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.
Freezing of Gait Questionnaire	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

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy