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| ID | Type | Description | Link |
|---|---|---|---|
| 0006095 PRE BIO CEN | Other Identifier | Comitato Etico Nazionale per le sperimentazioni degli Enti Pubblici di Ricerca |
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| Name | Class |
|---|---|
| Istituti Clinici Scientifici Maugeri SpA | OTHER |
| Villa Beretta Rehabilitation Center | OTHER |
| University of Pisa | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycling with Virtual Park | Experimental | Participants perform cycling training using a commercially available ergometer (THERA-Trainer Tigo) combined with the VirtualPark virtual reality system. The intervention includes simultaneous motor and cognitive training (dual-task), with cognitive exercises targeting attention, inhibition, working memory, and navigation during cycling. |
|
| Cycling withouth Virtual Park | Active Comparator | Participants perform standard cycling training using the ergometer (THERA-Trainer Tigo) without virtual reality. This represents conventional motor rehabilitation (supportive care) without the addition of cognitive tasks delivered through VirtualPark. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-task training with Virtual Reality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intrinsic Motivation | 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. | Baseline, Week 2, Week 5 |
| Motivation | 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. | Baseline, Week 2, Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Function | Workload on the cycle ergometer | Up to 5 weeks |
| Motor Funcion | Cycling assistance level | Up to 5 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Mondellini, Psychologist | Contact | 0039.0341.2350202 | marta.mondellini@cnr.it | |
| Cira Fundarò, MD | Contact | cira.fundaro@icsmaugeri.it |
| Name | Affiliation | Role |
|---|---|---|
| Marta Mondellini, Psychologist | Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato | Principal Investigator |
| Cira Fundarò, MD | Istituti Clinici Scientifici Maugeri IRCCS Montescano |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituti a Carattere Scientifico Maugeri Bari | Bari | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31607362 | Background | Xu X, Fu Z, Le W. Exercise and Parkinson's disease. Int Rev Neurobiol. 2019;147:45-74. doi: 10.1016/bs.irn.2019.06.003. Epub 2019 Jun 20. | |
| 37777748 | Background | Yu J, Wu J, Lu J, Wei X, Zheng K, Liu B, Xiao W, Shi Q, Xiong L, Ren Z. Efficacy of virtual reality training on motor performance, activity of daily living, and quality of life in patients with Parkinson's disease: an umbrella review comprising meta-analyses of randomized controlled trials. J Neuroeng Rehabil. 2023 Sep 30;20(1):133. doi: 10.1186/s12984-023-01256-y. |
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Individual participant data (IPD) will not be shared due to data protection and privacy constraints, and in accordance with applicable GDPR regulations and institutional policies.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2026 |
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Prospective, multicenter, randomized, cross-over pilot study
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| Cycling training | Device | Participants perform standard cycling training without virtual reality-based tasks |
|
| Week 2 or Week 5 |
| user experience in relation to the adoption of the proposed technology | 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. | Week 2 or Week 5 |
| Cognitive Function | 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. | Baseline, week 2, week 5, week 9 |
| Cognitive Function | The Short Stroop Test is one of the most commonly used tests to assess prefrontal functions such as cognitive flexibility and the control and inhibition of automatic responses. It is a timed test divided into three parts: in the first part, the subject must name the color of the squares presented to them; in the second part, they must simply read the words written on the board (color names); and in the third part, they are asked to name the color of the ink the words are written in (the board presents a series of color names, each printed in a different color than the one indicated by the name). The third part is reported by subjects as the most difficult. The Stroop effect emphasizes the interference that automatic word processing generates on the color-naming task, which is more demanding in terms of mental effort. Outcome include execution time and number of errors. Lower scores indicate better performance. | Baseline, Week 2, Week 5, Week 9 |
| Cognitive Function | The Frontal Assessment Battery (FAB) is a screening test that assesses the presence and severity of a dysexecutive disorder affecting both cognition and motor behavior. The test consists of six subtests that explore, in order: the ability to conceptualize and abstract categories, mental flexibility, motor planning ability, sensitivity to interference, inhibition control, and environmental autonomy. The total score is the sum of the individual subtest scores and ranges from 0 to 18 (cut-off 13.50/18). Higher scores indicate better executive functioning. | Baseline, Week 2, Week 5, Week 9 |
| Cognitive Function | Corsi Forward - Backward is a test designed to assess working memory and short-term visuospatial memory. The examiner places a board of nine cubes in front of the subject, which the subject will touch in sequences of increasing length. The subject must reproduce the sequence in the same order (Forward) or in reverse (Backward). Starting with a sequence of three cubes, the number of cubes the subject must memorize gradually increases. Outcome include the number of cubes correctly memorized. Higher scores indicate better visuospatial memory performance. | Baseline, Week 2, Week 5, Week 9 |
| Motor function | Cycling distance traveled during cycling training, measured in meters using ergometer-derived data | Up to 5 weeks |
| Functional abilities | The Modified Barthel Index (MBI) is a clinical tool used to assess independence in activities of daily living (ADLs) in patients with physical disabilities. The MBI evaluates ten specific functions: Feeding, Bathing, Grooming, Dressing, Bowel control, Bladder control, Toileting, Transfers (e.g., bed to chair), Mobility (e.g., walking or wheelchair use), Stair climbing. Each item is scored on a 5-level ordinal scale. Interpretation: 0-20, Total dependency; 21-60, Severe dependency; 61-90, Moderate dependency; 91-99, Slight dependency; 100, Independence | Baseline, Week 2, Week 5 |
| exercise tolerance | The Borg RPE scale (Rating of Perceived Exertion, 6-20) is used: ranges from 6 (minimal effort) to 20 (maximum effort) and is often used to assess the intensity of effort in sports and rehabilitation. This scale is widely used in the medical and sports fields to monitor patients' perceived exertion during rehabilitation exercises or physical activities. | Up to 5 weeks |
| exercise tolerance | Heart rate measured with finger pulse oximeter with medically certified devices | Up to 5 weeks |
| Exercise Tolerance | Oxygen saturation measured with finger pulse oximeter with medically certified devices | Up to 5 weeks |
| Device Security | The number and description of any adverse events that occurred and were attributable to the use of the device will be collected. | Up to 5 weeks |
| Christian Lunetta, MD | Istituti Clinici Scientifici Maugeri IRCCS Milano Camaldoli | Principal Investigator |
| Stefania De Trane, MD | Istituti Clinici Scientifici Maugeri IRCCS Bari | Principal Investigator |
| Laura Marcuccio, MD | Istituti Clinici Scientifici Maugeri IRCCS Telese | Principal Investigator |
| Chiara Pavese, MD | Istituti Clinici Scientifici Maugeri IRCCS Pavia | Principal Investigator |
| Franco Molteni, MD | Centro di Riabilitazione Villa Beretta | Principal Investigator |
| Carmelo Chisari, MD | University of Pisa | Principal Investigator |
| Istituti a Carattere Scientifico Maugeri Telese | Telese Terme | Benevento | 82037 | Italy |
|
| Centro di Riabilitazione Villa Beretta | Costa Masnaga | Lecco | 23845 | Italy |
|
| Istituti a Carattere Scientifico Maugeri Milano Camaldoli | Milan | Milano | 20138 | Italy |
|
| Istituti a Carattere Scientifico Maugeri Montescano | Montescano | Pavia | 27040 | Italy |
|
| Istituti a Carattere Scientifico Maugeri Pavia | Pavia | Pavia | 27100 | Italy |
|
| Università di Pisa | Pisa | Pisa | 56126 | Italy |
|
| 39468617 | Background | Wang L, Zhang H, Ai H, Liu Y. Effects of virtual reality rehabilitation after spinal cord injury: a systematic review and meta-analysis. J Neuroeng Rehabil. 2024 Oct 28;21(1):191. doi: 10.1186/s12984-024-01492-w. |
| 30558556 | Background | Trevizan IL, Silva TD, Dawes H, Massetti T, Crocetta TB, Favero FM, Oliveira ASB, de Araujo LV, Santos ACC, de Abreu LC, Coe S, Monteiro CBM. Efficacy of different interaction devices using non-immersive virtual tasks in individuals with Amyotrophic Lateral Sclerosis: a cross-sectional randomized trial. BMC Neurol. 2018 Dec 17;18(1):209. doi: 10.1186/s12883-018-1212-3. |
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| 35069171 | Background | Pelosin E, Ponte C, Putzolu M, Lagravinese G, Hausdorff JM, Nieuwboer A, Ginis P, Rochester L, Alcock L, Bloem BR, Nieuwhof F, Cereatti A, Della Croce U, Mirelman A, Avanzino L. Motor-Cognitive Treadmill Training With Virtual Reality in Parkinson's Disease: The Effect of Training Duration. Front Aging Neurosci. 2022 Jan 5;13:753381. doi: 10.3389/fnagi.2021.753381. eCollection 2021. |
| 30029502 | Background | Pedroli E, Greci L, Colombo D, Serino S, Cipresso P, Arlati S, Mondellini M, Boilini L, Giussani V, Goulene K, Agostoni M, Sacco M, Stramba-Badiale M, Riva G, Gaggioli A. Characteristics, Usability, and Users Experience of a System Combining Cognitive and Physical Therapy in a Virtual Environment: Positive Bike. Sensors (Basel). 2018 Jul 19;18(7):2343. doi: 10.3390/s18072343. |
| 35811514 | Background | Papaioannou T, Voinescu A, Petrini K, Stanton Fraser D. Efficacy and Moderators of Virtual Reality for Cognitive Training in People with Dementia and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2022;88(4):1341-1370. doi: 10.3233/JAD-210672. |
| 34184168 | Background | Aiello EN, Esposito A, Gramegna C, Gazzaniga V, Zago S, Difonzo T, Appollonio IM, Bolognini N. The Frontal Assessment Battery (FAB) and its sub-scales: validation and updated normative data in an Italian population sample. Neurol Sci. 2022 Feb;43(2):979-984. doi: 10.1007/s10072-021-05392-y. Epub 2021 Jun 29. |
| 28841846 | Background | Ohura T, Hase K, Nakajima Y, Nakayama T. Validity and reliability of a performance evaluation tool based on the modified Barthel Index for stroke patients. BMC Med Res Methodol. 2017 Aug 25;17(1):131. doi: 10.1186/s12874-017-0409-2. |
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| May 15, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2026 | May 15, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D000690 | Amyotrophic Lateral Sclerosis |
| D060825 | Cognitive Dysfunction |
| D009103 | Multiple Sclerosis |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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