Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease

Prof. Massimo Filippi

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training); Other: Upper limb/handwriting exercises in a real setting (RS-training); Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04876352

GR-2018-12366005

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: Under 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 3 patient groups

VR-training

Experimental group

Description:

Upper limb/handwriting exercises in an immersive virtual reality setting

Treatment:

Other: Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training)

RS-training

Active Comparator group

Description:

The same upper limb/handwriting exercises in a real setting

Treatment:

Other: Upper limb/handwriting exercises in a real setting (RS-training)

Healthy subjects

Other group

Description:

Age- and sex-matched healthy subjects recruited to compare clinical and fMRI characteristics at baseline.

Treatment:

Other: No intervention