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临床试验/NCT07094828
NCT07094828尚未招募不适用

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

University of Bergamo0 个研究点目标入组 86 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
86
主要终点
Dynamic postural control

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Researcher in charge of Data Analysis

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

Action Observation and Motor Imagery integrated with D-Wall technology

Experimental

干预措施: AOMI with D-Wall (Other)

Routine rehabilitative physiotherapy integrated with D-Wall technology

Active Comparator

干预措施: Routine physiotherapy with D-Wall (Other)

结局指标

主要结局

Dynamic postural control

时间窗: at baseline, at the fourth week (end of the intervention period), and at the eighth week (follow-up).

The Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used to assess dynamic postural control.

次要结局

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

研究者

发起方
University of Bergamo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Morganti

Associate Professor

University of Bergamo

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