Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

25. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Aktiv komparator: 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.
Enhed: Cycling training
Participants perform standard cycling training without virtual reality-based tasks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intrinsic Motivation
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Usability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Marta Mondellini

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

15. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Multipel sclerose

Kliniske forsøg med Dual-task training with Virtual Reality

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner