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Cerebral Palsy InfantileVR-PMPNCT06586125

Virtual Reality Impact on Powered Mobility: a Feasibility Study

An observational study of Cerebral Palsy Infantile and Neuromuscular Diseases in Children, run by Azienda Usl di Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 20 years
What is being tested?
Powered Mobility Training
How many people
10 participants
Where
1 siteItaly
Study dates
4 Sep 2023to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna, Bologna, 40139

Other trials in Italy

About this study

Official title: The Impact of Virtual Reality on Powered Mobility in Patients With Neuromotor Disabilities: a Feasibility Study

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.

Read the detailed description

Children diagnosed with Cerebral Palsy (CP) and neuromuscular diseases (NMDs) often face significant challenges in achieving independent mobility due to motor impairments. Powered mobility is a viable option, but it requires extensive training to ensure safe driving conditions. Typically, wheelchair training is conducted with therapists at the hospital, incurring considerable costs for the national health system. Additionally, 10-40% of people are unable to use a power wheelchair due to sensory, motor, and neurocognitive impairments. These individuals are deemed unable to drive safely and are often forced to use manual wheelchairs or rely on caregivers for support. Driving skills and appropriate aids for independent mobility are established based on the Powered Mobility Program (PMP). However, to date, no clinically validated tools exist to support user training in fulfilling the PMP requirements.

Virtual reality (VR) offers a portable solution for safe training at home. However, current VR simulators have not been developed to assess users\' driving skills, and they typically allow control via joysticks or hand trackers, which are unusable for individuals with severe upper limb motor impairments. In this context, brain-computer interfaces (BCIs) represent a potential innovative control interface.

Integrating VR into powered wheelchair (PW) training introduces new possibilities for enhancing rehabilitation programs by offering engaging and personalized experiences tailored to the unique needs of children with CP and NMDs. The VR Powered Mobility Program (VR-PMP), which integrates 3D gaming tailored to PMP tasks accessible via laptops or VR headsets, aims to harness the potential of VR to enhance PW training. VR-PMP seeks to facilitate motor learning through repetitive practice in realistic and engaging contexts.

The primary objective of this study is to assess the feasibility of using immersive and semi-immersive VR for powered mobility (PM) training and to determine the impact of VR technologies on PW driving skills in children with CP and NMDs, including those with severe upper limb motor impairments.

The secondary aims are:

To assess the impact of VR: evaluating the use of VR on the level of assistance, supervision, and autonomy in PW driving, measured through the overall PMP score, comparing PMP scores obtained before and after VR training to determine improvements in PW driving skills.

To correlate physiological signals collected during VR-PMP sessions with motion sickness and workload assessments to understand stress levels and engagement.

To investigate the usability and satisfaction with the VR PMP system through questionnaires and scales, focusing on the feasibility of home training sessions for driving practice.

Being tested
Powered Mobility Training
Keywords
Cerebral palsy, Neuromuscular diseases, Powered mobility, Virtual reality, Pediatric rehabilitation, Brain-computer interface
Medical subject headings
Cerebral Palsy, Neuromuscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Powered Mobility TrainingOther

    Also called Virtual Reality - based powered mobility training

    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.

Study groups in NCT06586125
Study groupRoleWhat they receive
VR - based trainingFive 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
Receives: Other: Powered Mobility Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from Tprel (day 1) to T13 (day 41)

Secondary outcomes (7)

  1. PMP (Powered Mobility Program) score

    The Powered Mobility Program (PMP) score assesses assistance, supervision, and autonomy in driving powered wheelchairs through 34 tasks. These tasks are categorized into basic skills, structured environment driving, and unstructured environment driving domains. Each task is scored from 0 (task not attempted) to 5 (age-appropriate supervision), with a maximum total score of 170 points. The total score is calculated by summing individual item scores and dividing by the number of completed tasks.

    Measured: T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41)

  2. QUEST-2 (Quebec User Evaluation of Satisfaction with Assistive Technology) questionnaire score

    The QUEST 2.0 questionnaire score is an outcome measurement that evaluates user's satisfaction with their assistive device. It is used to document the real-life benefits of assistive devices and justify their necessity. It comprises 12 items divided into two parts: Device (8 items) and Services (4 items). Each item is rated on a 5-point scale from 1 ("not satisfied at all") to 5 ("very satisfied"). The total score is the sum of valid item scores divided by the number of valid items.

    Measured: T0 (day 2), T13 (day41)

  3. MSAQ (Motion Sickness Assessment Questionnaire) score

    The MSAQ questionnaire assesses motion sickness. It consists of 16 questions divided into four subcategories: Gastrointestinal (G), Central (C), Peripheral (P), and Sopite-related (S). Responses are scored on a scale from 1 to 9 points. Each subcategory is scored individually, contributing to a total score ranging from 11 to 144 points. The overall motion sickness score is calculated as the percentage of total points scored: (sum of all item points / 144) × 100. Subscale scores are calculated similarly as percentages within each factor: (sum of gastrointestinal items / 36) × 100; (sum of central items / 45) × 100; (sum of peripheral items / 27) × 100; (sum of sopite items / 36) × 100.

    Measured: T1 (day 3), T6 (day 25), T12 (day 40)

  4. IPQ (iGroupPresence Questionnaire) score

    The IPQ questionnaire assesses sense of presence (SOP - level of immersion in VR) of a VR user. The IPQ consists of 14 items divided into four subcategories: spatial presence, involvement, perceived realism level, and a "sense of being present." All items are rated on a seven-point scale (0-6), with a higher score indicating greater SOP. The total score is obtained by summing the scores of individual items (from 0 to 84 points).

    Measured: T1 (day 3), T6 (day 25), T12 (day 40)

  5. NASA-TLX (NASA Task Load Index) score

    The NASA-TLX questionnaire score (National Aeronautics and Space Administration Task Load Index) measures physical and mental workload using six items related to mental load, physical activity, speed of performance, performance, effort, and frustration. Each item is accompanied by a 12 cm line scale divided into 20 equal intervals, anchored by binary descriptors (e.g., low/high), delimited by 21 vertical markers, and then converted to a scale from 0 to 100 points. To calculate the score for each scale, the number of lines marked by a participant is counted, 1 is subtracted, and the result is multiplied by 5. Weights from 0-5 will be assigned to the 15 subscale comparisons, which will be multiplied by the corresponding subscale score. The total score (from 0 to 100 points) is estimated by summing the weighted scores and dividing by 15.

    Measured: T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41)

  6. mNASA-TLX (modified NASA Task Load Index) score

    Participants will be asked to fill out a modified version of the NASA-TLX (mNASA-TLX), using the same questions but with a different scale ranging from 1 (low) to 5 (high). The scores will be then converted using the 0-100 points scale, as for the NASA-TLX.

    Measured: T2 (day 6), T3 (day 12), T4 (day 18), T5 (day 24), T7 (day 26), T8 (day 30), T9 (day 33), T10 (36), T11 (39)

  7. GDQ (Game Design Questionnaire) score

    The GDQ is a questionnaire to evaluate the user's satisfaction of the VR-PMP simulator. It assesses the usability of the graphical interface and user preferences (measured on a scale from 1 to 9 points) regarding colors, game animation, and avatars used. The total score is estimated by averaging the items.

    Measured: T1 (day 3), T6 (day 25), T12 (day 40)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start4 Sep 2023
  3. Primary completion20 Dec 2024
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06586125
Sponsor's protocol ID
002.2022.ISNB.NeuroRehab.MRI
Acronym
VR-PMP
Status last verified
Jul 2025
First submitted
28 Jun 2024
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27188686

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

    PubMed 23465426

  • 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.

    PubMed 22466379

  • 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.

    PubMed 29232181

  • 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.

    PubMed 11730152

  • 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.

    PubMed 33078704

  • 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.

    PubMed 24764156

  • 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.

    PubMed 15129405

  • 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.

    PubMed 37897432

  • 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.

    PubMed 29542110

  • 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.

    PubMed 38654367

  • 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.

    PubMed 37209934

  • 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.

    PubMed 15230460

  • 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.

    PubMed 35737961

  • 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.

    PubMed 32924663

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy Infantile and Neuromuscular Diseases in Children, run by Azienda Usl di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of dropout participants unable to use the VR-PMP simulator (time frame: from Tprel (day 1) to T13 (day 41)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06586125, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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