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

NCT ID: NCT04876352

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2024-09-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

VR-training

Upper limb/handwriting exercises in an immersive virtual reality setting

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

RS-training

The same upper limb/handwriting exercises in a real setting

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Healthy subjects

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

Group Type: OTHER

No intervention

Intervention Type: OTHER

Only baseline evaluations, without longitudinal assessment

Interventions

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

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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

No intervention

Only baseline evaluations, without longitudinal assessment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Massimo Filippi

OTHER

Sponsor Role: lead

Responsible Party

Prof. Massimo Filippi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS San Raffaele

Milan, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 40920242 (View on PubMed)

Other Identifiers

GR-2018-12366005

Identifier Type: -

Identifier Source: org_study_id