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Not Yet RecruitingNCT06814782

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Istituto Clinico Humanitas · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERAction Observation TrainingAction Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements
OTHERAction Observation and Motor ImageryAction Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements
OTHERExerciseAfter watching a landscape video, patients will have to perform specific postural and balance exercises

Timeline

Start date
2025-03-01
Primary completion
2026-03-01
Completion
2026-09-01
First posted
2025-02-07
Last updated
2025-02-07

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06814782. Inclusion in this directory is not an endorsement.

Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation in Patients with Parkinson's Di (NCT06814782) · Clinical Trials Directory