Post-strokeVP_AdultsNCT07616050
Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients
A study testing Dual-task training with Virtual Reality and Cycling training in people with Post-stroke and Parkinson Disease, run by Marta Mondellini at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis
- What is being tested?
- Dual-task training with Virtual Reality and Cycling training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesItaly
- Study dates
- Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cira Fundarò, MD contact
7 sites in 1 country
Italy7 sites
Istituti a Carattere Scientifico Maugeri Bari
Bari, Bari, 70124
Stefania De Trane, 0039-080-7814111, stefania.detrane@icsmaugeri.it
Centro di Riabilitazione Villa Beretta
Costa Masnaga, Lecco, 23845
Franco Molteni, 0039- 031-8544215, franco56.molteni@gmail.com
Istituti a Carattere Scientifico Maugeri Milano Camaldoli
Milan, Milano, 20138
Christian Lunetta, 0039-02-50725266, christian.lunetta@icsmaugeri.it
Istituti a Carattere Scientifico Maugeri Montescano
Montescano, Pavia, 27040
Cira Fundarò, 0039-0385-247268, cira.fundaro@icsmaugeri.it
Istituti a Carattere Scientifico Maugeri Pavia
Pavia, Pavia, 27100
Chiara Pavese, 0039-0382-592637, chiara.pavese@icsmaugeri.it
Università di Pisa
Pisa, Pisa, 56126
Carmelo Chisari, 0039-050-2210901, carmelo.chisari@unipi.it
Istituti a Carattere Scientifico Maugeri Telese
Telese Terme, Benevento, 82037
Laura Marcuccio, 0039-0824909250, laura.marcuccio@icsmaugeri.it
About this study
Official title: Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Training Motivation in Adult Patients
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.
Read more
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.
Read the 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.
- Conditions
- Post-stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Mild Cognitive Impairment (MCI), Multiple Sclerosis, Frailty at Older Adults
- Being tested
- Dual-task training with Virtual Reality, Cycling training
- 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
- Medical subject headings
- Parkinson Disease, Amyotrophic Lateral Sclerosis, Cognitive Dysfunction, Multiple Sclerosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task training with Virtual RealityDevice
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.
Cycling trainingDevice
Participants perform standard cycling training without virtual reality-based tasks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dual-task training with Virtual Reality |
| 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. Receives: Device: Cycling training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 2, Week 5
Secondary outcomes (6)
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 5, Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Post-strokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multicenter, randomized, cross-over pilot study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marta Mondellini
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, Villa Beretta Rehabilitation Center, University of Pisa
- Responsible party
- Sponsor-investigator, Marta Mondellini, Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
- Investigators
- Marta Mondellini, Psychologist, Principal investigator, Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero AvanzatoCira Fundarò, MD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS MontescanoChristian Lunetta, MD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS Milano CamaldoliStefania De Trane, MD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS BariLaura Marcuccio, MD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS TeleseChiara Pavese, MD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS PaviaFranco Molteni, MD, Principal investigator, Centro di Riabilitazione Villa BerettaCarmelo Chisari, MD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616050
- Sponsor's protocol ID
- VirtualPark_Adults
- Other IDs
- 0006095 PRE BIO CEN
- Acronym
- VP_Adults
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31607362Yu 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.
PubMed 37777748Wang 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.
PubMed 39468617Trevizan 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.
PubMed 30558556Tortora C, Di Crosta A, La Malva P, Prete G, Ceccato I, Mammarella N, Di Domenico A, Palumbo R. Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. Ageing Res Rev. 2024 Jan;93:102146. doi: 10.1016/j.arr.2023.102146. Epub 2023 Nov 28.
PubMed 38036103Siciliano M, Chiorri C, Battini V, Sant'Elia V, Altieri M, Trojano L, Santangelo G. Regression-based normative data and equivalent scores for Trail Making Test (TMT): an updated Italian normative study. Neurol Sci. 2019 Mar;40(3):469-477. doi: 10.1007/s10072-018-3673-y. Epub 2018 Dec 7.
PubMed 30535956Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.
PubMed 2760661Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
PubMed 26474316Poli L, Greco G, Gabriele M, Pepe I, Centrone C, Cataldi S, Fischetti F. Effect of Outdoor Cycling, Virtual and Enhanced Reality Indoor Cycling on Heart Rate, Motivation, Enjoyment and Intention to Perform Green Exercise in Healthy Adults. J Funct Morphol Kinesiol. 2024 Oct 2;9(4):183. doi: 10.3390/jfmk9040183.
PubMed 39449477Pelosin 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.
PubMed 35069171Pedroli 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.
PubMed 30029502Papaioannou 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.
PubMed 35811514Aiello 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.
PubMed 34184168Ohura 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.
PubMed 28841846Nuzum H, Stickel A, Corona M, Zeller M, Melrose RJ, Wilkins SS. Potential Benefits of Physical Activity in MCI and Dementia. Behav Neurol. 2020 Feb 12;2020:7807856. doi: 10.1155/2020/7807856. eCollection 2020.
PubMed 32104516
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Training Motivation in Adult Patients
- ClinicalTrials.gov ID
- NCT07616050
- Acronym / sponsor ID
- VP_Adults / VirtualPark_Adults
- Conditions
- Post-stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Mild Cognitive Impairment (MCI), Multiple Sclerosis, Frailty at Older Adults
- Keywords
- post-stroke, parkinson disease, Amyotrophic Lateral Sclerosis, Mild Cognitive Impairment, Multiple Sclerosis, spinal cord injury, rehabilitation, dual-task
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marta MondelliniUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, Villa Beretta Rehabilitation Center, University of Pisa
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, cross-over pilot study
| Arm | Type | Receives |
|---|---|---|
| Cycling with Virtual Park | Experimental | Device: Dual-task training with Virtual RealityParticipants 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 | Device: Cycling trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Dual-task training with Virtual RealityParticipants 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. | Device | Cycling with Virtual Park |
| Cycling trainingParticipants perform standard cycling training without virtual reality-based tasks | Device | Cycling withouth Virtual Park |
Primary outcome
Intrinsic Motivation
Time frame: 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
Time frame: 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.
6 secondary outcomes
Usability
Time frame: Week 2 or Week 5
user experience in relation to the adoption of the proposed technology
Time frame: Week 2 or Week 5
Cognitive Function
Time frame: Baseline, week 2, week 5, week 9
Cognitive Function
Time frame: Baseline, Week 2, Week 5, Week 9
Cognitive Function
Time frame: Baseline, Week 2, Week 5, Week 9
Cognitive Function
Time frame: Baseline, Week 2, Week 5, Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 31607362Xu 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.
- Background: PubMed 37777748Yu 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.
- Background: PubMed 39468617Wang 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.
- Background: PubMed 30558556Trevizan 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.
- Background: PubMed 38036103Tortora C, Di Crosta A, La Malva P, Prete G, Ceccato I, Mammarella N, Di Domenico A, Palumbo R. Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. Ageing Res Rev. 2024 Jan;93:102146. doi: 10.1016/j.arr.2023.102146. Epub 2023 Nov 28.
- Background: PubMed 30535956Siciliano M, Chiorri C, Battini V, Sant'Elia V, Altieri M, Trojano L, Santangelo G. Regression-based normative data and equivalent scores for Trail Making Test (TMT): an updated Italian normative study. Neurol Sci. 2019 Mar;40(3):469-477. doi: 10.1007/s10072-018-3673-y. Epub 2018 Dec 7.
- Background: PubMed 2760661Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.
- Background: PubMed 26474316Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
- Background: PubMed 39449477Poli L, Greco G, Gabriele M, Pepe I, Centrone C, Cataldi S, Fischetti F. Effect of Outdoor Cycling, Virtual and Enhanced Reality Indoor Cycling on Heart Rate, Motivation, Enjoyment and Intention to Perform Green Exercise in Healthy Adults. J Funct Morphol Kinesiol. 2024 Oct 2;9(4):183. doi: 10.3390/jfmk9040183.
- Background: PubMed 35069171Pelosin 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.
- Background: PubMed 30029502Pedroli 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.
- Background: PubMed 35811514Papaioannou 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.
- Individual participant dataSharing planned: No. 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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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.
Cira Fundarò, MD contact
Marta Mondellini, Psychologist principal investigator
Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Cira Fundarò, MD principal investigator
Istituti Clinici Scientifici Maugeri IRCCS Montescano
Christian Lunetta, MD principal investigator
Istituti Clinici Scientifici Maugeri IRCCS Milano Camaldoli
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task training with Virtual Reality and Cycling training in people with Post-stroke and Parkinson Disease, run by Marta Mondellini at 7 sites 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 11 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Mondellini, Psychologist (0039.0341.2350202, marta.mondellini@cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrinsic Motivation (time frame: Baseline, Week 2, Week 5). The study lists 2 primary outcomes in all. 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 NCT07616050, which also lists 29 linked publications.
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 29 May 2026.