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

NCT07616050 | Not Yet Recruiting

• 2 other identifiers: VirtualPark_Adults0006095 PRE BIO CEN
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this clinical study is to evaluate the feasibility, usability, and motivational impact of VirtualPark, a virtual reality-based dual-task rehabilitation system, in adults with neurological and age-related conditions. VirtualPark is a virtual reality application designed to deliver cognitive exercises during cycling training using a commercially available ergometer (THERA-Trainer Tigo). The system integrates physical and cognitive tasks in simulated real-life environments. The intervention integrates motor and cognitive training tasks targeting domains such as attention, inhibition, working memory, and navigation. This is a prospective, multicenter, randomized, cross-over pilot study. It will compare cycling training performed with and without virtual reality. Participants will complete both intervention conditions over a 4-week period separated by a wash-out phase with standard rehabilitation activities. The order of conditions will be randomized. The study will assess motivation during rehabilitation training, usability and user experience of the system, as well as exploratory effects on cognitive and motor performance, functional abilities, perceived exertion, and safety. The study will enroll adult participants (≥18 years) with conditions such as stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, mild cognitive impairment, spinal cord injury, and frail older adults.

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; virtual reality; intrinsic motivation; frail elderly patients with multiple comorbidities

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Usability

  Week 2 or Week 5

• user experience in relation to the adoption of the proposed technology

  Week 2 or Week 5

• Cognitive Function

  Baseline, week 2, week 5, week 9

• Cognitive Function

  Baseline, Week 2, Week 5, Week 9

• Cognitive Function

  Baseline, Week 2, Week 5, Week 9

Other Outcomes (8)

• Motor Function

  Up to 5 weeks

• Motor Funcion

  Up to 5 weeks

• Motor function

  Up to 5 weeks

Study Arms (2)

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.

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.

Device: Cycling training

Interventions

Cycling training DEVICE

Participants perform standard cycling training without virtual reality-based tasks

Cycling withouth Virtual Park

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.

Cycling with Virtual Park

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ongoing behavioral disorders.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marta Mondellini: lead
• Villa Beretta Rehabilitation Center: collaborator
• University of Pisa: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (7)

Istituti a Carattere Scientifico Maugeri Bari

Bari, Bari, 70124, Italy

Location

Istituti a Carattere Scientifico Maugeri Telese

Telese Terme, Benevento, 82037, Italy

Location

Centro di Riabilitazione Villa Beretta

Costa Masnaga, Lecco, 23845, Italy

Location

Istituti a Carattere Scientifico Maugeri Milano Camaldoli

Milan, Milano, 20138, Italy

Location

Istituti a Carattere Scientifico Maugeri Montescano

Montescano, Pavia, 27040, Italy

Location

Istituti a Carattere Scientifico Maugeri Pavia

Pavia, Pavia, 27100, Italy

Location

Università di Pisa

Pisa, Pisa, 56126, Italy

Location

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MeSH Terms

Conditions

Parkinson Disease; Amyotrophic Lateral Sclerosis; Cognitive Dysfunction; Multiple Sclerosis; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

Central Study Contacts

Marta Mondellini, Psychologist

CONTACT

0039.0341.2350202; marta.mondellini@cnr.it

Cira Fundarò, MD

CONTACT

cira.fundaro@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: Prospective, multicenter, randomized, cross-over pilot study

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)