Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation in Patients with Parkinson's Disease
TeleAOTPD
2 other identifiers
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedFebruary 7, 2025
February 1, 2025
1 year
January 10, 2025
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Timed Up and Go test
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.
From enrollment to the end of treatment at 8 weeks
Secondary Outcomes (23)
Timed Up and Go test
From enrollment to the end of follow-up at 3 months after end of training
Timed Up and Go test
From end of training to the end of follow-up at 3 months after end of training
Movement Disorders Society Unified PD Rating Scale
From enrollment to the end of treatment at 8 weeks
Movement Disorders Society Unified PD Rating Scale
From enrollment to the end follow-up (3 months after end of training)
Movement Disorders Society Unified PD Rating Scale
From end of training to the end follow-up (3 months after end of training)
- +18 more secondary outcomes
Other Outcomes (5)
Gait and gait initiation analysis
From enrollment to the end of treatment at 8 weeks
Gait and gait initiation analysis
From enrollment to the end follow-up (3 months after end of treatment)
Posture analysis
From enrollment to the end of treatment at 8 weeks
- +2 more other outcomes
Study Arms (3)
Action Observation Training Group (AOT)
EXPERIMENTALPatients 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.
Action Observation and Motor Imagery Group (AOMI)
EXPERIMENTALPatients 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.
Control group
ACTIVE COMPARATORPatients in this group will be exposed to four video presentations showing landscape. Patients will perform the same exercise of AOT groupimmediately after watching.
Interventions
Action Observation Training (AOT) consists of patients observing videos of specific movements, followed by practice of those movements
Action Observation and Motor Imagery (AOMI) consists of patients observing videos of specific movements, followed by mental rehearsal of those movements
After watching a landscape video, patients will have to perform specific postural and balance exercises
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Systemic, psychiatric, or other neurological illnesses influencing motor or functional performance
- a history of substance abuse influencing cognition or compliance
- visual disturbances
- head tremor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Clinico Humanitas
Rozzano, Milan, 20089, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2025
First Posted
February 7, 2025
Study Start
March 1, 2025
Primary Completion
March 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 7, 2025
Record last verified: 2025-02