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Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients (VP_Adults)

25 mei 2026 bijgewerkt door: Marta Mondellini

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.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Italië
    • Bari
      • Bari, Bari, Italië, 70124
    • Benevento
      • Telese Terme, Benevento, Italië, 82037
    • Lecco
      • Costa Masnaga, Lecco, Italië, 23845
        • Centro di Riabilitazione Villa Beretta
        • Contact:
    • Milano
      • Milan, Milano, Italië, 20138
        • Istituti a Carattere Scientifico Maugeri Milano Camaldoli
        • Contact:
    • Pavia
      • Montescano, Pavia, Italië, 27040
        • Istituti a Carattere Scientifico Maugeri Montescano
        • Contact:
      • Pavia, Pavia, Italië, 27100
        • Istituti a Carattere Scientifico Maugeri Pavia
        • Contact:
    • Pisa
      • Pisa, Pisa, Italië, 56126

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cycling with Virtual Park
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.
Apparaat: Dual-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.
Actieve vergelijker: Cycling withouth Virtual Park
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.
Apparaat: Cycling training
Participants perform standard cycling training without virtual reality-based tasks

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intrinsic Motivation
Tijdsspanne: 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.
Baseline, Week 2, Week 5
Motivation
Tijdsspanne: 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.
Baseline, Week 2, Week 5

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Usability
Tijdsspanne: 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."
Week 2 or Week 5
user experience in relation to the adoption of the proposed technology
Tijdsspanne: 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.
Week 2 or Week 5
Cognitive Function
Tijdsspanne: 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.
Baseline, week 2, week 5, week 9
Cognitive Function
Tijdsspanne: Baseline, Week 2, Week 5, Week 9
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
Tijdsspanne: Baseline, Week 2, Week 5, Week 9
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
Tijdsspanne: Baseline, Week 2, Week 5, Week 9
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Motor Function
Tijdsspanne: Up to 5 weeks
Workload on the cycle ergometer
Up to 5 weeks
Motor Funcion
Tijdsspanne: Up to 5 weeks
Cycling assistance level
Up to 5 weeks
Motor function
Tijdsspanne: Up to 5 weeks
Cycling distance traveled during cycling training, measured in meters using ergometer-derived data
Up to 5 weeks
Functional abilities
Tijdsspanne: Baseline, Week 2, Week 5
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
Tijdsspanne: Up to 5 weeks
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
Tijdsspanne: Up to 5 weeks
Heart rate measured with finger pulse oximeter with medically certified devices
Up to 5 weeks
Exercise Tolerance
Tijdsspanne: Up to 5 weeks
Oxygen saturation measured with finger pulse oximeter with medically certified devices
Up to 5 weeks
Device Security
Tijdsspanne: Up to 5 weeks
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Marta Mondellini

Medewerkers

University of Pisa
Istituti Clinici Scientifici Maugeri SpA
Villa Beretta Rehabilitation Center

Onderzoekers

  • Hoofdonderzoeker: Marta Mondellini, Psychologist, Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
  • Hoofdonderzoeker: Cira Fundarò, MD, Istituti Clinici Scientifici Maugeri IRCCS Montescano
  • Hoofdonderzoeker: Christian Lunetta, MD, Istituti Clinici Scientifici Maugeri IRCCS Milano Camaldoli
  • Hoofdonderzoeker: Stefania De Trane, MD, Istituti Clinici Scientifici Maugeri IRCCS Bari
  • Hoofdonderzoeker: Laura Marcuccio, MD, Istituti Clinici Scientifici Maugeri IRCCS Telese
  • Hoofdonderzoeker: Chiara Pavese, MD, Istituti Clinici Scientifici Maugeri IRCCS Pavia
  • Hoofdonderzoeker: Franco Molteni, MD, Centro di Riabilitazione Villa Beretta
  • Hoofdonderzoeker: Carmelo Chisari, MD, University of Pisa

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

15 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

25 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VirtualPark_Adults
  • 0006095 PRE BIO CEN (Andere identificatie: Comitato Etico Nazionale per le sperimentazioni degli Enti Pubblici di Ricerca)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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