Virtual Reality Impact on Powered Mobility: a Feasibility Study

NCT06586125 | Completed

• 1 other identifier: 002.2022.ISNB.NeuroRehab.MRI
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy Infantile; Neuromuscular Diseases in Children

Keywords

Cerebral palsy; Neuromuscular diseases; Powered mobility; Virtual reality; Pediatric rehabilitation; Brain-computer interface

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• 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)

Study Arms (1)

VR - based training

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

Other: Powered Mobility Training

Interventions

Powered Mobility Training OTHER

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.

Also known as: Virtual Reality - based powered mobility training

VR - based training

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Both sexes
• Age between 6 and 20 years
• Clinical diagnosis: Central motor disability with Gross Motor Function Classification Scale (GMFCS) levels 3-4-5
• Owner of a powered wheelchair or a manual wheelchair with an electric propulsion system
• Powered Mobility Program (PMP) score \> 0 in basic skills
• Signed informed consent

You may not qualify if:

• Participants who do not tolerate the use of immersive VR (e.g., development of motion sickness-related symptoms)
• Severe cognitive impairments

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Bologna, 40139, Italy

Location

Related Publications (22)

• 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.

  PMID: 27188686 BACKGROUND

• Mercuri E, Muntoni F. Muscular dystrophies. Lancet. 2013 Mar 9;381(9869):845-60. doi: 10.1016/S0140-6736(12)61897-2.

  PMID: 23465426 BACKGROUND

• 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.

  PMID: 22466379 BACKGROUND

• 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.

  PMID: 29232181 BACKGROUND

• 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.

  PMID: 11730152 BACKGROUND

• 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.

  PMID: 33078704 BACKGROUND

• 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.

  PMID: 24764156 BACKGROUND

• 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.

  PMID: 15129405 BACKGROUND

• 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.

  PMID: 37897432 BACKGROUND

• 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.

  PMID: 29542110 BACKGROUND

• 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.

  PMID: 38654367 BACKGROUND

• 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.

  PMID: 37209934 BACKGROUND

• 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.

  PMID: 15230460 BACKGROUND

• 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.

  PMID: 35737961 BACKGROUND

• 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.

  PMID: 32924663 BACKGROUND

• 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.

  PMID: 31805790 BACKGROUND

• 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.

  PMID: 31115048 BACKGROUND

• 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.

  PMID: 35833624 BACKGROUND

• 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.

  PMID: 11508406 BACKGROUND

• 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.

  PMID: 11211039 BACKGROUND

• 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.

  PMID: 34411151 BACKGROUND

• 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.

  PMID: 24720100 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Antonella Cersosimo, Dr.

  IRCCS Istituto delle Scienze Neurologiche di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: September 19, 2024
• Study Start: September 4, 2023
• Primary Completion: December 20, 2024
• Study Completion: June 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)