Effects of Action Observation Training and Motor Imagery Delivered by Telerehabilitation on Mobility, Posture and Brain Plasticity in Patients with Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Timed Up and Go test
研究概览
简要总结
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
详细描述
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).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Systemic, psychiatric, or other neurological illnesses influencing motor or functional performance
- •a history of substance abuse influencing cognition or compliance
- •visual disturbances
- •head tremor
研究组 & 干预措施
Action Observation Training Group (AOT)
Patients 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.
干预措施: Action Observation Training (Other)
Action Observation and Motor Imagery Group (AOMI)
Patients 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.
干预措施: Action Observation and Motor Imagery (Other)
Control group
Patients in this group will be exposed to four video presentations showing landscape. Patients will perform the same exercise of AOT groupimmediately after watching.
干预措施: Exercise (Other)
结局指标
主要结局
Timed Up and Go test
时间窗: From enrollment to the end of treatment at 8 weeks
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.
次要结局
- Movement Disorders Society Unified PD Rating Scale(From end of training to the end follow-up (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)
- Mini-BEST Test(From end of treatment to the end of follow-up (3 months after end of treatment))
- 6-Minute Walking test(From end of treatment to the end of follow-up (3 months after end of treatment))
- Functional Independence Measure (FIM)(From end of treatment to the end of follow-up (3 months after end of treatment))
- Parkinson's disease Questionnaire - 39 items (PDQ-39)(From end of treatment to the end of follow-up (3 months after end of treatment))
- 10-Meter Walking test(From end of treatment to the end of follow-up (3 months after end of treatment))
- Freezing of Gait Questionnaire(From end of treatment to the end follow-up (3 months after end of treatment))
- Timed Up and Go test(From enrollment 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))
- Functional Independence Measure (FIM)(From enrollment to the end of treatment at 8 weeks)
- Functional Independence Measure (FIM)(From enrollment to the end follow-up (3 months after end of training))
- Parkinson's disease Questionnaire - 39 items (PDQ-39)(From enrollment to the end of treatment at 8 weeks)
- Parkinson's disease Questionnaire - 39 items (PDQ-39)(From enrollment to the end follow-up (3 months after end of treatment))
- Mini-BEST Test(From enrollment to the end of treatment at 8 weeks)
- Mini-BEST Test(From enrollment to the end follow-up (3 months after end of treatment))
- 10-Meter Walking test(From enrollment to the end of treatment at 8 weeks)
- 10-Meter Walking test(From enrollment to the end follow-up (3 months after end of treatment))
- 6-Minute Walking test(From enrollment to the end of treatment at 8 weeks)
- 6-Minute Walking test(From enrollment to the end follow-up (3 months after end of treatment))
- Freezing of Gait Questionnaire(From enrollment to the end of treatment at 8 weeks)
- Freezing of Gait Questionnaire(From enrollment to the end follow-up (3 months after end of treatment))