Integration of Augmented Visual Feedback in Action Observation and Motor Imagery Therapy for Parkinson's Disease

Official title

Integration of Augmented Visual Feedback Into Action Observation and Motor Imagery Therapy for Parkinson's Disease: A Randomized Controlled Trial

Overview

Improving movement control during rehabilitation is still a challenge for people with Parkinson's Disease, mainly because of the motor symptoms caused by the condition. However, new technologies offer promising ways to support therapy. This clinical trial will test whether using TecnoBody® D-Wall technology integrated with two techniques (Action Observation and Motor Imagery) can improve physiotherapy outcomes for people with Parkinson's Disease. The TecnoBody® D-Wall is a type of digital mirror that includes a 3D camera, pressure-sensitive platforms, and a screen. It shows a person's body movements in real time and gives visual feedback on joint mobility, balance, and how weight is distributed during movement. Action Observation and Motor Imagery are two techniques already used in physiotherapy. Action Observation involves watching someone perform a movement, while Motor Imagery involves mentally rehearsing the movement before doing it. Studies have shown that both techniques activate the same brain areas involved in actual movement. In this trial, after watching and imagining the movement, participants will perform the exercise in front of the D-Wall. This setup gives them real-time feedback to help improve how they move, a new approach for these techniques. To see if this approach works, we will measure balance using a test validated for people with Parkinson's Disease and assess mobility using lab-based gait analysis, which tracks how a person walks. Participants in the study will: * Be receiving routine physiotherapy at a hospital that is specialized in Parkinson's Disease rehabilitation. * Be randomly assigned to one of two groups: 1) One group will receive physiotherapy incorporating the D-Wall alongside Action Observation and Motor Imagery; 2) The other group will receive physiotherapy incorporating the D-Wall but, without Action Observation or Motor Imagery. * Take part in therapy for up to four weeks, followed by another four weeks of monitoring, for a total of up to two months. * Complete some initial tests to check if they are eligible for the study. This study includes patients who have been diagnosed with idiopathic Parkinson's Disease and are undergoing rehabilitation as part of their usual hospital care. The intervention lasts as long as their regular hospital stay.

Interventions

• Other AOMI with D-Wall
  The intervention group will follow routine rehabilitative activity in the morning and will perform one hour of Action Observation and Motor Imagery training with augmented visual feedback (D-Wall) in the afternoon, three times a week. Each session will be conducted as follows: first AO (Action Observation), then MI (Motor Imagery). During the MI phase, participants will be asked to imagine the motor tasks and then perform them, receiving real-time augmented visual feedback provided by the digit
• Other Routine physiotherapy with D-Wall
  The control group will also follow routine rehabilitative activity in the morning, while in the afternoon they will perform motor training of the same duration, without Action Observation and Motor Imagery, but solely with augmented visual feedback (D-Wall), with the same weekly frequency.

Primary outcome measures

• Dynamic postural control [Time frame: at baseline, at the fourth week (end of the intervention period), and at the eighth week (follow-up).]

Secondary outcome measures (1)

• Moviment analysis [Time frame: at baseline, at the fourth week (end of the intervention period), and at the eighth week (follow-up).]

Eligibility criteria

Inclusion criteria

• diagnosis of idiopathic Parkinson's disease for at least 5 years;
• stable medication regimen for at least 4 weeks;
• no cognitive impairment according to the Mini-Mental State Examination;
• at stage ≤3 on the Hoehn \& Yahr scale;
• provide informed consent to participate.

Exclusion criteria

• undergoing advanced therapies (e.g., deep brain stimulation or infusion pump therapy);
• unable to walk independently for at least 5 meters without assistive devices;
• substance abuse;
• with visual, orthopedic, or other medical conditions that could hinder the execution of activities;
• history of other neurological disorders (other than Parkinson's disease).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07094828 · 0026841/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗