Virtual Reality Impact on Powered Mobility: a Feasibility Study

NCT ID: NCT06586125

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-04

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy Infantile Neuromuscular Diseases in Children

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Powered Mobility Training

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Virtual Reality - based powered mobility training

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonella Cersosimo, Dr.

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto delle Scienze Neurologiche di Bologna

Locations

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IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Bologna, Italy

Site Status

Countries

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Italy

References

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Other Identifiers

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002.2022.ISNB.NeuroRehab.MRI

Identifier Type: -

Identifier Source: org_study_id

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