Clinical trial NCT06814782: Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation in Patients with Parkinson's Disease
Official title: Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation on Mobility, Posture and Brain Plasticity in Patients with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Action Observation
Motor Imagery
Telerehabilitation
Parkinson disease
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Timed Up and Go test
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Timed Up and Go test
timeFrame: From enrollment to the end of follow-up at 3 months after end of training
measure: Timed Up and Go test
timeFrame: From end of training to the end of follow-up at 3 months after end of training
measure: Movement Disorders Society Unified PD Rating Scale
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Movement Disorders Society Unified PD Rating Scale
timeFrame: From enrollment to the end follow-up (3 months after end of training)
measure: Movement Disorders Society Unified PD Rating Scale
timeFrame: From end of training to the end follow-up (3 months after end of training)
measure: Functional Independence Measure (FIM)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Functional Independence Measure (FIM)
timeFrame: From enrollment to the end follow-up (3 months after end of training)
measure: Functional Independence Measure (FIM)
timeFrame: From end of treatment to the end of follow-up (3 months after end of treatment)
measure: Parkinson's disease Questionnaire - 39 items (PDQ-39)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Parkinson's disease Questionnaire - 39 items (PDQ-39)
timeFrame: From enrollment to the end follow-up (3 months after end of treatment)
measure: Parkinson's disease Questionnaire - 39 items (PDQ-39)
timeFrame: From end of treatment to the end of follow-up (3 months after end of treatment)
measure: Mini-BEST Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Mini-BEST Test
timeFrame: From enrollment to the end follow-up (3 months after end of treatment)
measure: Mini-BEST Test
timeFrame: From end of treatment to the end of follow-up (3 months after end of treatment)
measure: 10-Meter Walking test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 10-Meter Walking test
timeFrame: From enrollment to the end follow-up (3 months after end of treatment)
measure: 10-Meter Walking test
timeFrame: From end of treatment to the end of follow-up (3 months after end of treatment)
measure: 6-Minute Walking test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 6-Minute Walking test
timeFrame: From enrollment to the end follow-up (3 months after end of treatment)
measure: 6-Minute Walking test
timeFrame: From end of treatment to the end of follow-up (3 months after end of treatment)
measure: Freezing of Gait Questionnaire
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Freezing of Gait Questionnaire
timeFrame: From enrollment to the end follow-up (3 months after end of treatment)
measure: Freezing of Gait Questionnaire
timeFrame: From end of treatment to the end follow-up (3 months after end of treatment)
Other outcomes:
measure: Gait and gait initiation analysis
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Gait and gait initiation analysis
timeFrame: From enrollment to the end follow-up (3 months after end of treatment)
measure: Posture analysis
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Posture analysis
timeFrame: From enrollment to the end follow-up (3 months after end of treatment)
measure: Functional Magnetic Resonance Imaging
timeFrame: From enrollment to the end of treatment at 8 weeks
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
References: