Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Other: Upper limb/handwriting exercises in a real setting (RS-training)Other: Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training)Other: No intervention
- Registration Number
- NCT04876352
- Lead Sponsor
- Prof. Massimo Filippi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RS-training Upper limb/handwriting exercises in a real setting (RS-training) The same upper limb/handwriting exercises in a real setting VR-training Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training) Upper limb/handwriting exercises in an immersive virtual reality setting Healthy subjects No intervention Age- and sex-matched healthy subjects recruited to compare clinical and fMRI characteristics at baseline.
- Primary Outcome Measures
Name Time Method Letters amplitude 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
- Secondary Outcome Measures
Name Time Method Repetitive Prewriting task on tablet Baseline, after 8 weeks of training and after 3-month follow-up 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
Brain functional changes during hand-tapping in a virtual reality setting Baseline, after 8 weeks of training and after 3-month follow-up 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 Baseline, after 8 weeks of training and after 3-month follow-up 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.
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 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 Baseline, after 8 weeks of training and after 3-month follow-up 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.
Funnel task on tablet Baseline, after 8 weeks of training and after 3-month follow-up 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.
Velocity of swipe-slide finger movements on a screen Baseline, after 8 weeks of training and after 3-month follow-up 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 Baseline, after 8 weeks of training and after 3-month follow-up 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.
Cambridge Neuropsychological Test Automated Battery (CANTAB) Baseline, after 8 weeks of training and after 3-month follow-up 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.
Hand tapping task Baseline, after 8 weeks of training and after 3-month follow-up 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 Baseline, after 8 weeks of training and after 3-month follow-up 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.
Rubber Hand Illusion paradigm Baseline, after 8 weeks of training and after 3-month follow-up 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.
Manual Ability Measure (MAM-36) questionnaire Baseline, after 8 weeks of training and after 3-month follow-up 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.
Parkinson's Disease Questionnaire (PDQ-39) score Baseline, after 8 weeks of training and after 3-month follow-up 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.
Purdue Pegboard Test (PPT) Baseline, after 8 weeks of training and after 3-month follow-up 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.
Trial Locations
- Locations (1)
IRCCS San Raffaele
🇮🇹Milan, Italy