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

NCT04876352 | Completed DMC

• 1 other identifier: GR-2018-12366005
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Letters amplitude

  Changes in letters amplitude during a repetitive handwriting task on a writing tablet. Higher amplitude reflects a better performance. Assessment during ON medication phase

  Baseline, after 8 weeks of training and after 3-month follow-up

Secondary Outcomes (15)

• 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

• Repetitive Prewriting task on 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

• Brain functional changes during hand-tapping in a virtual reality setting

  Baseline, after 8 weeks of training and after 3-month follow-up

Study Arms (3)

VR-training

EXPERIMENTAL

Upper limb/handwriting exercises in an immersive virtual reality setting

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

RS-training

ACTIVE COMPARATOR

The same upper limb/handwriting exercises in a real setting

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

Healthy subjects

OTHER

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

Other: No intervention

Interventions

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

Progressively difficult multimodal physiotherapy under the augmented visual feedback induced by the VR. Participants will wear a head-mounted display and their upper limb movements during the training will be captured by a motion tracker. Patients will perform: repetition of movements of upper limb single joints (shoulder, elbow and wrist) under the augmented visual feedback provided by the use of VR in increasingly wide range of movement; active upper limb multi-joints movements under the augmented visual feedback provided by the use of VR (following trajectories designed in the virtual space - movement involving shoulder, elbow and wrist joints) and handwriting tasks and touch screen technology usage in VR context on a tablet and a smartphone. 30 minutes of exercises, 2 times a week, for 8 weeks.

VR-training

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

Participants will perform progressively difficult multimodal physiotherapy in a real setting. Participants will be encouraged to perform their upper limb movements during the training in order to perform faster and ampler movements. They will perform: repetition of movements of upper limb single joints (shoulder, elbow and wrist) in increasingly wide range of movement under the feedback provided by therapist; active upper limb multi-joints movements under the feedback provided by the therapist (following trajectories designed on a table or on a blackboard - movements involving shoulder, elbow and wrist joints) and handwriting tasks and touch screen technology usage under the supervision of the therapist. 30 minutes of exercises, 2 times a week, for 8 weeks.

RS-training

No intervention OTHER

Only baseline evaluations, without longitudinal assessment

Healthy subjects

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Prof. Massimo Filippi: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

Related Publications (1)

• Corbetta D, Sarasso E, Gardoni A, Zenere L, Balestrino R, Smits-Engelsman B, Pelosin E, Filippi M, Agosta F. Construct validity, intrarater and interrater reliability of the Italian version of the systematic screening of handwriting difficulties (SOS) test in people with Parkinson's disease. J Neurol. 2025 Sep 8;272(9):620. doi: 10.1007/s00415-025-13365-w.

  PMID: 40920242 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physiotherapist, neurologists, neuropsychologists and radiologist assessing the patients are blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: May 17, 2021
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)