Clinical trial NCT06586125: Virtual Reality Impact on Powered Mobility: a Feasibility Study
Official title: The Impact of Virtual Reality on Powered Mobility in Patients with Neuromotor Disabilities: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy Infantile
Neuromuscular Diseases in Children
Keywords: Cerebral palsy
Neuromuscular diseases
Powered mobility
Virtual reality
Pediatric rehabilitation
Brain-computer interface
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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\&#39; 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of dropout participants unable to use the VR-PMP simulator
timeFrame: from Tprel (day 1) to T13 (day 41)
Secondary outcomes:
measure: PMP (Powered Mobility Program) score
timeFrame: T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41)
measure: QUEST-2 (Quebec User Evaluation of Satisfaction with Assistive Technology) questionnaire score
timeFrame: T0 (day 2), T13 (day41)
measure: MSAQ (Motion Sickness Assessment Questionnaire) score
timeFrame: T1 (day 3), T6 (day 25), T12 (day 40)
measure: IPQ (iGroupPresence Questionnaire) score
timeFrame: T1 (day 3), T6 (day 25), T12 (day 40)
measure: NASA-TLX (NASA Task Load Index) score
timeFrame: T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41)
measure: mNASA-TLX (modified NASA Task Load Index) score
timeFrame: 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)
measure: GDQ (Game Design Questionnaire) score
timeFrame: T1 (day 3), T6 (day 25), T12 (day 40)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche di Bologna
Study officials:
affiliation: IRCCS Istituto delle Scienze Neurologiche di Bologna
name: Antonella Cersosimo, Dr.
role: PRINCIPAL_INVESTIGATOR
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