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

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

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

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

No intervention

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

IRCCS San RaffaeleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

VR-training

RS-training

Healthy subjects

Arm Description

Upper limb/handwriting exercises in an immersive virtual reality setting

The same upper limb/handwriting exercises in a real setting

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04876352

First Posted

May 3, 2021

Last Updated

December 6, 2021

Sponsor

Prof. Massimo Filippi

1. Study Identification

Unique Protocol Identification Number

NCT04876352

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

May 17, 2021 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Massimo Filippi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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=15) will undergo clinical, physiotherapy, neuropsychological and MRI assessments only at study entry as a benchmark.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 15 healthy age- and sex-matched control is included at baseline

Masking

Outcomes Assessor

Masking Description

Physiotherapist, neurologists, neuropsychologists and radiologist assessing the patients are blinded to group allocation.

Allocation

Randomized

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VR-training

Arm Type

Experimental

Arm Description

Upper limb/handwriting exercises in an immersive virtual reality setting

Arm Title

RS-training

Arm Type

Active Comparator

Arm Description

The same upper limb/handwriting exercises in a real setting

Arm Title

Healthy subjects

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

No intervention

Intervention Description

Only baseline evaluations, without longitudinal assessment

Primary Outcome Measure Information:

Title

Letters amplitude

Description

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

Time Frame