Clinical and Brain Functional MRI Effects of a Rehabilitative Training of Upper Limb Using Immersive Virtual Reality in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Letters amplitude
研究概览
简要总结
The aim of this study is to assess the effect of 8-week physiotherapy training using immersive virtual reality (VR-training) compared to a physiotherapy training performed in a real setting (RS-training) on handwriting and touch screen technology-based activities, brain functional activity and cognition in patients with Parkinson's disease (PD). Both groups will perform upper limb exercises focused at improving movement amplitude and speed during several activities such as writing and using touch screen-technology. Participants randomized to VR-training (N=20) will perform exercises under the augmented visual feedback induced by the VR aimed at stimulating movement amplitude and speed. Participants randomized to RS-training (N=20) will perform exercises in a real setting.
Before training, after training (8 weeks) and at 3-month follow-up (20 weeks), subjects with PD will undergo clinical evaluations (neurological, physiotherapy and neuropsychological) while taking their regular anti-parkinsonian drugs (on-medication state). MRI scans will be acquired at each time-point to assess brain activity reorganization during off state (MRI scans will be acquired at least 12 hours after the regular evening dopaminergic therapy administration to mitigate the pharmacological effects on neural activity). A sample of matched healthy subjects (N=30) will undergo clinical, physiotherapy, neuropsychological and MRI assessments only at study entry as a benchmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Physiotherapist, neurologists, neuropsychologists and radiologist assessing the patients are blinded to group allocation.
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for PD patients:
- •Diagnosis of idiopathic Parkinson's disease
- •H&Y scale ≤ 3 while on medication
- •Age ≤ 85 years
- •Right-handedness with the Edinburgh Handedness Inventory Quotient
- •Right-side involvement according to H&Y and Movement Disorder Society Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III)
- •Handwriting difficulty defined by a score greater than or equal to 1 on item II.7 of the MDS-UPDRS
- •Oral and written informed consent to study participation
- •Inclusion criteria for healthy controls:
- •Sex-matched and age-matched with PD patients;
- •Right-handed;
- •Oral and written informed consent to study participation.
排除标准
- •for PD patients:
- •Mini-Mental State Examination lower than 24;
- •Visual impairments that interfere with the immersive virtual environment;
- •(Other) upper limb deficits impeding handwriting;
- •History of (other) systemic, neurologic, psychiatric diseases, head injury and cerebrovascular alterations visible at an MRI scan;
- •Family history of neurodegenerative disorders;
- •History of alcohol and/or psychotropic drug abuse;
- •Contraindications for MRI;
- •Denied oral and written informed consent to study participation.
- •Exclusion criteria for healthy controls:
- •Mini-Mental State Examination lower than 28;
- •Visual impairments that interfere with the immersive virtual environment;
- •History of systemic, neurologic, psychiatric diseases, head injury and cerebrovascular alterations visible at an MRI scan;
- •History of alcohol and/or psychotropic drug abuse;
- •Contraindications for MRI;
- •Denied oral and written informed consent to study participation
研究组 & 干预措施
VR-training
Upper limb/handwriting exercises in an immersive virtual reality setting
干预措施: Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training) (Other)
RS-training
The same upper limb/handwriting exercises in a real setting
干预措施: Upper limb/handwriting exercises in a real setting (RS-training) (Other)
Healthy subjects
Age- and sex-matched healthy subjects recruited to compare clinical and fMRI characteristics at baseline.
干预措施: No intervention (Other)
结局指标
主要结局
Letters amplitude
时间窗: Baseline, after 8 weeks of training and after 3-month follow-up
Changes in letters amplitude during a repetitive handwriting task on a writing tablet. Higher amplitude reflects a better performance. Assessment during ON medication phase
次要结局
- Hand tapping task(Baseline, after 8 weeks of training and after 3-month follow-up)
- Repetitive Prewriting task on tablet(Baseline, after 8 weeks of training and after 3-month follow-up)
- Brain functional changes during hand-tapping in a virtual reality setting(Baseline, after 8 weeks of training and after 3-month follow-up)
- Brain functional changes during hand-tapping in a real setting(Baseline, after 8 weeks of training and after 3-month follow-up)
- Systematic Screening of Handwriting Difficulties test (SOS)(Baseline, after 8 weeks of training and after 3-month follow-up)
- Systematic Screening of Handwriting Difficulties test (SOS) on a tablet(Baseline, after 8 weeks of training and after 3-month follow-up)
- Funnel task on tablet(Baseline, after 8 weeks of training and after 3-month follow-up)
- Velocity of swipe-slide finger movements on a screen(Baseline, after 8 weeks of training and after 3-month follow-up)
- Velocity of finger tapping movements on a screen(Baseline, after 8 weeks of training and after 3-month follow-up)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, after 8 weeks of training and after 3-month follow-up)
- Finger tapping task(Baseline, after 8 weeks of training and after 3-month follow-up)
- Rubber Hand Illusion paradigm(Baseline, after 8 weeks of training and after 3-month follow-up)
- Manual Ability Measure (MAM-36) questionnaire(Baseline, after 8 weeks of training and after 3-month follow-up)
- Parkinson's Disease Questionnaire (PDQ-39) score(Baseline, after 8 weeks of training and after 3-month follow-up)
- Purdue Pegboard Test (PPT)(Baseline, after 8 weeks of training and after 3-month follow-up)
研究者
Prof. Massimo Filippi
Professor
IRCCS San Raffaele