Amyotrophic Lateral Sclerosis, Frailty at Older Adults, Mild Cognitive Impairment (MCI), Multiple Sclerosis, Parkinson Disease, Post-stroke
Conditions
Keywords
post-stroke, parkinson disease, Amyotrophic Lateral Sclerosis, Mild Cognitive Impairment, Multiple Sclerosis, spinal cord injury, rehabilitation, dual-task, virtual reality, intrinsic motivation, frail elderly patients with multiple comorbidities
Brief summary
The purpose of this clinical study is to evaluate the feasibility, usability, and motivational impact of VirtualPark, a virtual reality-based dual-task rehabilitation system, in adults with neurological and age-related conditions. VirtualPark is a virtual reality application designed to deliver cognitive exercises during cycling training using a commercially available ergometer (THERA-Trainer Tigo). The system integrates physical and cognitive tasks in simulated real-life environments. The intervention integrates motor and cognitive training tasks targeting domains such as attention, inhibition, working memory, and navigation. This is a prospective, multicenter, randomized, cross-over pilot study. It will compare cycling training performed with and without virtual reality. Participants will complete both intervention conditions over a 4-week period separated by a wash-out phase with standard rehabilitation activities. The order of conditions will be randomized. The study will assess motivation during rehabilitation training, usability and user experience of the system, as well as exploratory effects on cognitive and motor performance, functional abilities, perceived exertion, and safety. The study will enroll adult participants (≥18 years) with conditions such as stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, mild cognitive impairment, spinal cord injury, and frail older adults.
Detailed description
This study is a prospective, multicenter, randomized, cross-over pilot investigation evaluating the feasibility, usability, motivational impact, and preliminary clinical effects of a virtual reality-based dual-task rehabilitation system (VirtualPark) in adults with neurological and age-related conditions. VirtualPark is a non-immersive virtual reality application developed by CNR-STIIMA to support multimodal rehabilitation through the integration of cognitive exercises with cycling training performed on a commercially available medical ergometer (THERA-Trainer Tigo). The system allows participants to perform motor and cognitive tasks simultaneously within simulated real-life virtual environments, including park and city scenarios. Cognitive exercises target attention, inhibition, working memory, and navigational abilities, with adjustable difficulty levels adapted to the participant's clinical condition and performance. During the intervention, participants will undergo both experimental and control conditions according to a randomized cross-over design: * Virtual reality condition (VR): cycling training combined with VirtualPark serious games; * Non-virtual reality condition (No-VR): cycling training alone without virtual reality. Each participant will complete a 4-week intervention period consisting of 2 weeks in one condition (VR or No-VR), followed by a wash-out period involving standard rehabilitation activities, and 2 weeks in the alternate condition. The order of conditions will be randomized using block randomization to reduce order effects. Training sessions will be administered three times per week under supervision of trained healthcare professionals. Each session will include a 5-10 minute warm-up phase, 20 minutes of active or active-assisted cycling training, and a 5-10 minute cool-down phase. During the VR condition, cognitive tasks will be performed concurrently with cycling activity. Cycling speed detected by the ergometer will be translated into navigation speed within the virtual environment. Participants will interact with the system using Bluetooth buttons mounted on the ergometer handles. Assessments will be conducted at baseline (T0), after the first intervention phase (T1), after the second intervention phase (T2), and at 1-month follow-up (T3, cognitive outcomes only). The primary objective is to evaluate intrinsic and situational motivation associated with the use of virtual reality during rehabilitation training. Secondary objectives include assessment of usability, user experience, cognitive performance, motor performance, functional independence, perceived exertion, and device safety. The study population includes adults aged 18 years or older with neurological or frailty-related conditions, including stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, mild cognitive impairment, spinal cord injury, and frail older adults.
Interventions
DEVICEDual-task training with Virtual Reality
Participants perform cycling training using a commercially available ergometer combined with a non-immersive virtual reality system. Virtual Reality offers cognitive exercises targeting attention, inhibition, working memory, and navigation during cycling.
DEVICECycling training
Participants perform standard cycling training without virtual reality-based tasks
Sponsors
Marta Mondellini
Istituti Clinici Scientifici Maugeri SpA
Villa Beretta Rehabilitation Center
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, randomized, cross-over pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent to the study * subjects \> 18 years and \<85 years * diagnosis of MCI according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders VTh Edition (DSM V TR American Psychological Association 2013) * detection of ischemic stroke within 6 months preceding the study, frail elderly subjects (Gobbens RJ et al. 2010) * subjects affected by idiopathic Parkinson's disease according to the MDS-PD criteria (Postuma et al., 2015) * subjects affected by possible, probable and definite ALS according to the revised El Escorial criteria (Brooks Br, et al. 2000) * subjects affected by MS according to the McDonald criteria (2017) with disability measured with the EDSS (Expanded Disability Status Scale) \<= 8 * patients with spinal cord injury of different etiology with incomplete spinal cord injury, AIS (ASIA impairment scale) grade C and D, MMSE \>18 * subjects naïve to the use of the RV * no therapeutic changes or rehabilitation interventions in the month prior to inclusion in the study * no ongoing behavioral disorders.
Exclusion criteria
* Other concomitant neurological pathologies in addition to the one under study * presence of visual disturbances that do not allow access to the experimental virtual reality protocol * presence of impaired cardiorespiratory function or other organic instabilities that contraindicate ergometer training * severe osteoporosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrinsic Motivation | Baseline, Week 2, Week 5 | It is evaluated with the Interest/Enjoyment subscale of the Intrinsic Motivation Inventory (IMI). It is a part of a questionnaire, composed of 7 items to be answered on a 7-point Likert scale. For each statement, participants must provide a level of agreement on a scale of 1 to 7, where 1 equals "strongly disagree" and 7 equals "strongly agree." . Total scores range from 7 to 49, with higher scores indicating greater intrinsic motivation and enjoyment during rehabilitation training. |
| Motivation | Baseline, Week 2, Week 5 | the patient's motivational spectrum is assessed using the Situational Motivation Scale (SIMS), a self-report questionnaire. It consists of 16 items rated on a 7-point Likert scale and investigates four factors: intrinsic motivation, identified regulation, external regulation, and amotivation. For each statement, participants must provide a level of agreement on a scale of 1 to 7, where 1 equals "strongly disagree" and 7 equals "strongly agree." . Total scores range from 4 to 28 on each subscale, with higher scores indicating greater presence of that type of motivation towards rehabilitation activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | Week 2 or Week 5 | evaluated with the System Usability Scale (SUS); it is a post-study questionnaire consisting of 10 questions answered on a 5-point Likert scale. For each statement, participants must provide a level of agreement on a scale of 1 to 5, where 1 equals "strongly disagree" and 5 equals "strongly agree." The SUS results in a score ranging from 0 to 100, allowing not only an assessment of a system's usability but also its comparison with other systems. Higher scores indicate higher perceived usability of the system. For each statement, participants must provide a level of agreement on a scale of 1 to 5, where 1 equals "strongly disagree" and 5 equals "strongly agree." |
| user experience in relation to the adoption of the proposed technology | Week 2 or Week 5 | assessed with the Technology-Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The instrument consists of 29 items and explores the following factors: perceived usability, positive emotions, feelings of obstacle/difficulty, and feelings of stress. The items are to be answered on a 4-point Likert scale, where 1 corresponds to "not at all" and 4 to "very much". Higher scores indicate a more positive user experience. |
| Cognitive Function | Baseline, week 2, week 5, week 9 | Trail Making Test A-B is designed to assess selective, sustained, and divided attention, as well as any deficits in visual-motor coordination. In Trail Making Test A, the subject must match all 25 numbers on the sheet of paper in ascending order as quickly as possible. If the subject is able to complete the first part of the test, Trail Making Test B can be administered. It is administered in the same way, but the subject must match numbers and letters alternating between them as quickly as possible. This test allows for an assessment of psychomotor speed, visuospatial search ability, selective memory, and selective attention. Results include completion time in seconds. Lower completion times indicate better cognitive performance. |
Countries
Italy
Contacts
CONTACTMarta Mondellini, Psychologist
CONTACTCira Fundarò, MD
PRINCIPAL_INVESTIGATORMarta Mondellini, Psychologist
Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
PRINCIPAL_INVESTIGATORCira Fundarò, MD
Istituti Clinici Scientifici Maugeri IRCCS Montescano
PRINCIPAL_INVESTIGATORChristian Lunetta, MD
Istituti Clinici Scientifici Maugeri IRCCS Milano Camaldoli
PRINCIPAL_INVESTIGATORStefania De Trane, MD
Istituti Clinici Scientifici Maugeri IRCCS Bari
PRINCIPAL_INVESTIGATORLaura Marcuccio, MD
Istituti Clinici Scientifici Maugeri IRCCS Telese
PRINCIPAL_INVESTIGATORChiara Pavese, MD
Istituti Clinici Scientifici Maugeri IRCCS Pavia
PRINCIPAL_INVESTIGATORFranco Molteni, MD
Centro di Riabilitazione Villa Beretta
PRINCIPAL_INVESTIGATORCarmelo Chisari, MD
University of Pisa
Outcome results
None listed