NCT06586125|Completed
Virtual Reality Impact on Powered Mobility: a Feasibility Study
VR-PMP
The Impact of Virtual Reality on Powered Mobility in Patients With Neuromotor Disabilities: a Feasibility Study
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VR-PMP
The Impact of Virtual Reality on Powered Mobility in Patients With Neuromotor Disabilities: a Feasibility Study
Sponsor study identifier
observational
10
1 country
1
Study Start
September 4, 2023
Actual (reported)Primary Completion
December 20, 2024
Actual (reported)Study Completion
June 30, 2025
Actual (reported)This study explores the potential of Virtual Reality (VR) technology to enhance powered wheelchair (PW) training for children diagnosed with Cerebral Palsy (CP) and neuromuscular diseases (NMDs). The primary objective is to improve mobility and independence by employing immersive VR games and simulations within a powered mobility program (PMP) framework. The research involve testing a VR-powered mobility program (VR-PMP) simulator, which integrates 3D gaming tailored with PMP tasks accessible via laptops or VR headsets. Specifically designed for children with severe movement limitations, the study incorporates Brain-Computer Interfaces (BCIs), enabling interaction within the VR environment without conventional controllers. The study aims to evaluate whether these innovative VR tools can facilitate safer and independent wheelchair navigation for these children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2023
Actual (reported)June 28, 2024
Actual (reported)September 19, 2024
Actual (reported)December 20, 2024
Actual (reported)June 30, 2025
Actual (reported)Number of dropout participants unable to use the VR-PMP simulator
This outcome assesses the capability of using the VR-PMP (Virtual Reality-Powered Mobility Program) simulator by observing dropout rates, from 0 participant to 10 participants due to technology issues (e.g., equipment usability, motion sickness), as well as satisfaction levels with VR (Virtual Reality) hardware and software.
from Tprel (day 1) to T13 (day 41)
PMP (Powered Mobility Program) score
T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41)
QUEST-2 (Quebec User Evaluation of Satisfaction with Assistive Technology) questionnaire score
T0 (day 2), T13 (day41)
MSAQ (Motion Sickness Assessment Questionnaire) score
T1 (day 3), T6 (day 25), T12 (day 40)
IPQ (iGroupPresence Questionnaire) score
T1 (day 3), T6 (day 25), T12 (day 40)
NASA-TLX (NASA Task Load Index) score
T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41)
Five children and adolescents with cerebral palsy and/or neuromuscular disease and five children and adolescents with cerebral palsy and/or neuromuscular disease with difficulties to control the VR joysticks
The study procedure aims to observe the partecipants' behaviour while using the Virtual Reality - Power Mobility Program (VR-PMP) simulator applied during Power Mobility Training in clinical practice for 15 sessions. Participants use either semi-immersive mode (laptop screen with VR-PMP simulator) or immersive mode (head-mounted display with VR-PMP simulator). Five out of ten children unable to use conventional VR controllers or alternative access technologies available on the market, use brain-computer interface (BCI) developed specifically for these children to control the VR-PMP simulator.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study will enroll up to ten pediatric participants diagnosed with cerebral palsy (CP) or neuromuscular diseases (NMDs) who require powered wheelchair for their mobility.
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Bologna, 40139, Italy
Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
Mercuri E, Muntoni F. Muscular dystrophies. Lancet. 2013 Mar 9;381(9869):845-60. doi: 10.1016/S0140-6736(12)61897-2.
Jones MA, McEwen IR, Neas BR. Effects of power wheelchairs on the development and function of young children with severe motor impairments. Pediatr Phys Ther. 2012 Summer;24(2):131-40; discussion 140. doi: 10.1097/PEP.0b013e31824c5fdc.
Antonella Cersosimo, Dr.
IRCCS Istituto delle Scienze Neurologiche di Bologna
10 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2024
First Posted
September 19, 2024
Study Start
September 4, 2023
Actual (reported)BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone/muscle in Children with Cerebral Palsy
Contact the study team to confirm eligibility.
Rosen L, Plummer T, Sabet A, Lange ML, Livingstone R. RESNA position on the application of power mobility devices for pediatric users. Assist Technol. 2023 Jan 2;35(1):14-22. doi: 10.1080/10400435.2017.1415575. Epub 2018 Mar 26.
Bottos M, Bolcati C, Sciuto L, Ruggeri C, Feliciangeli A. Powered wheelchairs and independence in young children with tetraplegia. Dev Med Child Neurol. 2001 Nov;43(11):769-77. doi: 10.1017/s0012162201001402.
Bray N, Kolehmainen N, McAnuff J, Tanner L, Tuersley L, Beyer F, Grayston A, Wilson D, Edwards RT, Noyes J, Craig D. Powered mobility interventions for very young children with mobility limitations to aid participation and positive development: the EMPoWER evidence synthesis. Health Technol Assess. 2020 Oct;24(50):1-194. doi: 10.3310/hta24500.
Livingstone R, Field D. Systematic review of power mobility outcomes for infants, children and adolescents with mobility limitations. Clin Rehabil. 2014 Oct;28(10):954-64. doi: 10.1177/0269215514531262. Epub 2014 Apr 24.
Kirby RL, Dupuis DJ, Macphee AH, Coolen AL, Smith C, Best KL, Newton AM, Mountain AD, Macleod DA, Bonaparte JP. The wheelchair skills test (version 2.4): measurement properties. Arch Phys Med Rehabil. 2004 May;85(5):794-804. doi: 10.1016/j.apmr.2003.07.007.
Gefen N, Weiss PL, Rigbi A, Rosenberg L. Lessons learned from a pediatric powered mobility lending program. Disabil Rehabil Assist Technol. 2024 Aug;19(6):2250-2259. doi: 10.1080/17483107.2023.2276232. Epub 2023 Oct 28.
Field DA, Livingstone RW. Power mobility skill progression for children and adolescents: a systematic review of measures and their clinical application. Dev Med Child Neurol. 2018 Oct;60(10):997-1011. doi: 10.1111/dmcn.13709. Epub 2018 Mar 14.
Fraudet B, Leblong E, Piette P, Nicolas B, Gouranton V, Babel M, Devigne L, Pasteau F, Gallien P. Evaluation of power wheelchair driving performance in simulator compared to driving in real-life situations: the SIMADAPT (simulator ADAPT) project-a pilot study. J Neuroeng Rehabil. 2024 Apr 23;21(1):60. doi: 10.1186/s12984-024-01354-5.
Faure C, Routhier F, Lettre J, Choukou MA, Archambault PS. Effectiveness of the miWe Simulator Training on Powered Wheelchair-driving Skills: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Sep;104(9):1371-1377. doi: 10.1016/j.apmr.2023.04.022. Epub 2023 May 19.
Furumasu J, Guerette P, Tefft D. Relevance of the Pediatric Powered Wheelchair Screening Test for children with cerebral palsy. Dev Med Child Neurol. 2004 Jul;46(7):468-74. doi: 10.1017/s0012162204000775.
Gefen N, Archambault PS, Rigbi A, Weiss PL. Pediatric powered mobility training: powered wheelchair versus simulator-based practice. Assist Technol. 2023 Sep 3;35(5):389-398. doi: 10.1080/10400435.2022.2084183. Epub 2022 Jun 23.
Gefen N, Rigbi A, Weiss PLT. Reliability and validity of pediatric powered mobility outcome measures. Disabil Rehabil Assist Technol. 2022 Nov;17(8):882-887. doi: 10.1080/17483107.2020.1819449. Epub 2020 Sep 12.
Gefen N, Rigbi A, Archambault PS, Weiss PL. Comparing children's driving abilities in physical and virtual environments. Disabil Rehabil Assist Technol. 2021 Aug;16(6):653-660. doi: 10.1080/17483107.2019.1693644. Epub 2019 Dec 5.
Gefen N, Rigbi A, Weiss PL. Predictive model of proficiency in powered mobility of children and young adults with motor impairments. Dev Med Child Neurol. 2019 Dec;61(12):1416-1422. doi: 10.1111/dmcn.14264. Epub 2019 May 21.
Gefen N, Rosenberg L. Development of a new tool: progression of paediatric powered mobility- 3PM. Disabil Rehabil Assist Technol. 2024 Feb;19(2):465-473. doi: 10.1080/17483107.2022.2099020. Epub 2022 Jul 14.
Demers L, Weiss-Lambrou R, Ska B. Item analysis of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). Assist Technol. 2000;12(2):96-105. doi: 10.1080/10400435.2000.10132015.
Gianaros PJ, Muth ER, Mordkoff JT, Levine ME, Stern RM. A questionnaire for the assessment of the multiple dimensions of motion sickness. Aviat Space Environ Med. 2001 Feb;72(2):115-9.
Salimi Z, Ferguson-Pell MW. Motion sickness and sense of presence in a virtual reality environment developed for manual wheelchair users, with three different approaches. PLoS One. 2021 Aug 19;16(8):e0255898. doi: 10.1371/journal.pone.0255898. eCollection 2021.
Laurie-Rose C, Frey M, Ennis A, Zamary A. Measuring perceived mental workload in children. Am J Psychol. 2014 Spring;127(1):107-25. doi: 10.5406/amerjpsyc.127.1.0107.
Primary Completion
December 20, 2024
Actual (reported)Study Completion
June 30, 2025
Actual (reported)Last Updated
August 1, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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