Clinical trial NCT04876352: Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease
Official title: Clinical and Brain Functional MRI Effects of a Rehabilitative Training of Upper Limb Using Immersive Virtual Reality in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 70
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled trial. 40 PD patients are randomly divided into two groups: 20 in the VR-training (experimental) and 20 in the RS-training (active comparator). The assessors are blinded to the group allocation. In addition, a group of 30 healthy age- and sex-matched control is included at baseline
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion criteria 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.

Exclusion criteria 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

Primary outcomes:
measure: Letters amplitude
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
Secondary outcomes:
measure: Systematic Screening of Handwriting Difficulties test (SOS)
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Systematic Screening of Handwriting Difficulties test (SOS) on a tablet
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Repetitive Prewriting task on tablet
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Funnel task on tablet
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Brain functional changes during hand-tapping in a virtual reality setting
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Brain functional changes during hand-tapping in a real setting
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Hand tapping task
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Finger tapping task
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Velocity of swipe-slide finger movements on a screen
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Velocity of finger tapping movements on a screen
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Rubber Hand Illusion paradigm
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Parkinson's Disease Questionnaire (PDQ-39) score
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Manual Ability Measure (MAM-36) questionnaire
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
measure: Purdue Pegboard Test (PPT)
timeFrame: Baseline, after 8 weeks of training and after 3-month follow-up
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
References: