NCT04876352Completed
Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease
Clinical and Brain Functional MRI Effects of a Rehabilitative Training of Upper Limb Using Immersive Virtual Reality in People With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 8 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 3 May 2021
- Start date
- 17 May 2021
- Primary completion date
- 6 Sept 2024
- Lead sponsor
- Prof. Massimo Filippi
- Diseases
- Parkinson disease
- NCT number
- NCT04876352
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 17 May 2021 to the primary completion date, 6 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- History of systemic, neurologic, psychiatric diseases, head injury and cerebrovascular alterations visible at an MRI scan;
- History of alcohol and/or psychotropic drug abuse;
Other
- Mini-Mental State Examination lower than 24;
- Visual impairments that interfere with the immersive virtual environment;
- (Other) upper limb deficits impeding handwriting;
- Contraindications for MRI;
- Denied oral and written informed consent to study participation.
- Mini-Mental State Examination lower than 28;
- Visual impairments that interfere with the immersive virtual environment;
- Contraindications for MRI;
- Denied oral and written informed consent to study participation
Who the study is looking for
- 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
- Sex-matched and age-matched with PD patients;
- Right-handed;
- Oral and written informed consent to study participation.
Age in the registry: - to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.