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

Official title

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

Overview

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.

Interventions

• Device 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.
• Device Cycling training
  Participants perform standard cycling training without virtual reality-based tasks

Primary outcome measures

• Intrinsic Motivation [Time frame: Baseline, Week 2, Week 5]
• Motivation [Time frame: Baseline, Week 2, Week 5]

Secondary outcome measures (6)

• Usability [Time frame: Week 2 or Week 5]
• user experience in relation to the adoption of the proposed technology [Time frame: Week 2 or Week 5]
• Cognitive Function [Time frame: Baseline, week 2, week 5, week 9]
• Cognitive Function [Time frame: Baseline, Week 2, Week 5, Week 9]
• Cognitive Function [Time frame: Baseline, Week 2, Week 5, Week 9]
• Cognitive Function [Time frame: Baseline, Week 2, Week 5, Week 9]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 7 centers

• Istituti a Carattere Scientifico Maugeri Bari — Bari
• Istituti a Carattere Scientifico Maugeri Telese — Telese Terme
• Centro di Riabilitazione Villa Beretta — Costa Masnaga
• Istituti a Carattere Scientifico Maugeri Milano Camaldoli — Milan
• Istituti a Carattere Scientifico Maugeri Montescano — Montescano
• Istituti a Carattere Scientifico Maugeri Pavia — Pavia
• Università di Pisa — Pisa

Publications

• Xu X, Fu Z, Le W. Exercise and Parkinson's disease. Int Rev Neurobiol. 2019;147:45-74. doi: 10.1016/bs.irn.2019.06.003. Epub 2019 Jun 20. PMID 31607362
• Yu J, Wu J, Lu J, Wei X, Zheng K, Liu B, Xiao W, Shi Q, Xiong L, Ren Z. Efficacy of virtual reality training on motor performance, activity of daily living, and quality of life in patients with Parkinson's disease: an umbrella review comprising meta-analyses of randomized controlled trials. J Neuroeng Rehabil. 2023 Sep 30;20(1):133. doi: 10.1186/s12984-023-01256-y. PMID 37777748
• Wang L, Zhang H, Ai H, Liu Y. Effects of virtual reality rehabilitation after spinal cord injury: a systematic review and meta-analysis. J Neuroeng Rehabil. 2024 Oct 28;21(1):191. doi: 10.1186/s12984-024-01492-w. PMID 39468617
• Trevizan IL, Silva TD, Dawes H, Massetti T, Crocetta TB, Favero FM, Oliveira ASB, de Araujo LV, Santos ACC, de Abreu LC, Coe S, Monteiro CBM. Efficacy of different interaction devices using non-immersive virtual tasks in individuals with Amyotrophic Lateral Sclerosis: a cross-sectional randomized trial. BMC Neurol. 2018 Dec 17;18(1):209. doi: 10.1186/s12883-018-1212-3. PMID 30558556
• Tortora C, Di Crosta A, La Malva P, Prete G, Ceccato I, Mammarella N, Di Domenico A, Palumbo R. Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. Ageing Res Rev. 2024 Jan;93:102146. doi: 10.1016/j.arr.2023.102146. Epub 2023 Nov 28. PMID 38036103
• Siciliano M, Chiorri C, Battini V, Sant'Elia V, Altieri M, Trojano L, Santangelo G. Regression-based normative data and equivalent scores for Trail Making Test (TMT): an updated Italian normative study. Neurol Sci. 2019 Mar;40(3):469-477. doi: 10.1007/s10072-018-3673-y. Epub 2018 Dec 7. PMID 30535956
• Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6. PMID 2760661
• Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424. PMID 26474316

Identifiers

NCT: NCT07616050 · VirtualPark_Adults · 0006095 PRE BIO CEN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗