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

Sponsor
Marta Mondellini
Study ID
NCT07616050
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 training — DEVICE
    Participants perform standard cycling training without virtual reality-based tasks

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Intrinsic Motivation [ Time Frame: Baseline, Week 2, Week 5 ]

Central Contacts

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