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ClinicalTrials.gov ID

NCT07616050

Lead Sponsor

Marta MondelliniOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

70Estimated

Last Update Posted

May 29, 2026Actual

Start Date

Jun 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Jan 2027Estimated

Official Title

Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Training Motivation in Adult Patients

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.

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.

• Post-stroke
• Parkinson Disease
• Amyotrophic Lateral Sclerosis
• Mild Cognitive Impairment (MCI)
• Multiple Sclerosis
• Frailty at Older Adults

• Dual-task training with Virtual Reality
• Cycling training

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Marta MondelliniOTHER

Collaborators

Istituti Clinici Scientifici Maugeri SpAOTHER

Villa Beretta Rehabilitation CenterOTHER

University of PisaOTHER

carmelo.chisari@unipi.it0039-050-2210901