Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Training Motivation in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 7
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究者
Marta Mondellini
Researcher
Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato