Parkinson DiseaseNCT04876352
Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease
A study testing Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training) and Upper limb/handwriting exercises in a real setting (RS-training) in people with Parkinson Disease, run by Prof. Massimo Filippi at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training) and Upper limb/handwriting exercises in a real setting (RS-training)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2021to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training), Upper limb/handwriting exercises in a real setting (RS-training), No intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
No interventionOther
Only baseline evaluations, without longitudinal assessment
| Study group | Role | What they receive |
|---|---|---|
| VR-training | Experimental | Upper limb/handwriting exercises in an immersive virtual reality setting Receives: 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 Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Secondary outcomes (15)
Systematic Screening of Handwriting Difficulties test (SOS)
Systematic Screening of Handwriting Difficulties test assesses handwriting quality on a paper sheet. Patients copy 5 sentences. Handwriting quality is evaluated using five items: (i) fluency in letter formation; (ii) connections between letters; (iii) regularity of letter size; (iv) space between words; and (v) straightness of the sentence. Each item is evaluated with a score ranging from zero to two. A score of zero is given when the handwriting problem does not occur or is only present in one sentence. A score of one is given if the problem appears in two or three sentences and a score of two when the problem occurs in more than three sentences. The total SOS-score is the sum of the scores on the five criteria with a range from 0 to 10, with higher scores reflecting worse quality of handwriting. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Systematic Screening of Handwriting Difficulties test (SOS) on a tablet
SOS will be repeated also on a tablet with a touch-screen pen in order to assess handwriting quality on tablet. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Repetitive Prewriting task on tablet
Repetitive Prewriting task consists in writing specific loop figures, which reflect the essential components of writing on a tablet with a pen. Movement amplitude and speed will be recorded. Higher amplitude and speed reflect better results. Assessment during ON medication phase
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Funnel task on tablet
Funnel task consists in alternating upstroke and down stroke writing-like movements at varying amplitudes on a tablet with a pen to assess freezing during writing. Movement amplitude and speed will be recorded. Higher amplitude and speed reflect better results, number of interruptions during writing will be recorded to assess freezing severity. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Brain functional changes during hand-tapping in a virtual reality setting
Changes in functional MRI brain activity assessed during hand-tapping task in a virtual reality setting. Assessment during OFF medication phase, at least 12 hours after last medication assumption.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Brain functional changes during hand-tapping in a real setting
Changes in functional MRI brain activity assessed during hand-tapping task in a real setting. Assessment during OFF medication phase, at least 12 hours after last medication assumption.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Hand tapping task
Amplitude and speed of hand tapping performed with electromagnetic sensors placed on the hand. Higher movement amplitude and speed reflect better performance. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Finger tapping task
Amplitude and speed of finger tapping performed with electromagnetic sensors placed on the hand. Higher movement amplitude and speed reflect better performance. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Velocity of swipe-slide finger movements on a screen
Velocity of swipe-slide movements of the fingers on a smartphone screen. Movements usually employed to unlock and use smartphones/tablets. Number of movements in a given time and velocity of movements reflect better performance. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Velocity of finger tapping movements on a screen
Velocity of tapping movements of the fingers on a smartphone screen. Movements usually employed to unlock and use smartphones/tablets. Number of movements in a given time and velocity of movements reflect better performance. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Rubber Hand Illusion paradigm
Rubber hand illusion assesses bodily self-awareness and sense of agency. Patients report in a 10-points level scale their agreement relatively to nine statements reflecting how is the perception of their real hand relative to the rubber hand. Higher scores reflect higher illusion. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Cambridge Neuropsychological Test Automated Battery (CANTAB)
This battery of cognitive tests assesses executive-attentive functions, memory and visuospatial abilities. Lower reaction time and greater number of correct responses reflect better performance. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Parkinson's Disease Questionnaire (PDQ-39) score
Parkinson's Disease Questionnaire investigates the quality of life of PD patients. It includes 39 questions with 5 possible answers (never, occasionally, sometimes, often, always) and 8 sub-items related to mobility, ADLs, emotional well-being, signs of discouragement, social support, cognitions, communication and bodily discomfort. The maximum score is 100 and a low score is an indicator of a good quality of life.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Manual Ability Measure (MAM-36) questionnaire
The Manual Ability Measurement (MAM-36) includes 36 items assessing perceived ease or difficulty in performing common tasks (e.g. eating, dressing, button clothes). Items are rated on a 4-point scale from one "I cannot do it" to four "I can do it without any problem". A zero-response option is also included, indicating tasks that are almost never performed, with or without hand impairment. Scores on the 36 items are summed to create a total score with a range from 36 to 144, with higher scores reflecting higher ability.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Purdue Pegboard Test (PPT)
Purdue Pegboard Test is a widely used test to assess upper limb motor function and activity. Patient is asked to place pegs vertically in a board in front of him as fast as possible for 30 seconds. Higher number of placed pegs reflects a better performance. Assessment during ON medication phase.
Measured: Baseline, after 8 weeks of training and after 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start17 May 2021
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Massimo Filippi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Massimo Filippi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876352
- Sponsor's protocol ID
- GR-2018-12366005
- Status last verified
- Apr 2025
- First submitted
- 3 May 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40920242
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04876352
- Acronym / sponsor ID
- GR-2018-12366005
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Prof. Massimo FilippiUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| VR-training | Experimental | Other: Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training)Upper limb/handwriting exercises in an immersive virtual reality setting |
| RS-training | Active comparator | Other: Upper limb/handwriting exercises in a real setting (RS-training)The same upper limb/handwriting exercises in a real setting |
| Healthy subjects | Other | Other: No interventionAge- and sex-matched healthy subjects recruited to compare clinical and fMRI characteristics at baseline. |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | VR-training |
| 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. | Other | RS-training |
| No interventionOnly baseline evaluations, without longitudinal assessment | Other | Healthy subjects |
Primary outcome
Letters amplitude
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Changes in letters amplitude during a repetitive handwriting task on a writing tablet. Higher amplitude reflects a better performance. Assessment during ON medication phase
15 secondary outcomes
Systematic Screening of Handwriting Difficulties test (SOS)
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Systematic Screening of Handwriting Difficulties test (SOS) on a tablet
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Repetitive Prewriting task on tablet
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Funnel task on tablet
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Brain functional changes during hand-tapping in a virtual reality setting
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Brain functional changes during hand-tapping in a real setting
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Hand tapping task
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Finger tapping task
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Velocity of swipe-slide finger movements on a screen
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Velocity of finger tapping movements on a screen
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Rubber Hand Illusion paradigm
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Parkinson's Disease Questionnaire (PDQ-39) score
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Manual Ability Measure (MAM-36) questionnaire
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Purdue Pegboard Test (PPT)
Time frame: Baseline, after 8 weeks of training and after 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 40920242Corbetta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training) and Upper limb/handwriting exercises in a real setting (RS-training) in people with Parkinson Disease, run by Prof. Massimo Filippi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Letters amplitude (time frame: Baseline, after 8 weeks of training and after 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.