Virtual Reality Impact on Powered Mobility: a Feasibility Study
- Conditions
- Cerebral Palsy InfantileNeuromuscular Diseases in Children
- Interventions
- Other: Powered Mobility Training
- Registration Number
- NCT06586125
- Lead Sponsor
- Azienda Usl di Bologna
- 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\' 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- Participants who do not tolerate the use of immersive VR (e.g., development of motion sickness-related symptoms)
- Severe cognitive impairments
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VR - based training Powered Mobility 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
- Primary Outcome Measures
Name Time Method Number of dropout participants unable to use the VR-PMP simulator from Tprel (day 1) to T13 (day 41) 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.
- Secondary Outcome Measures
Name Time Method PMP (Powered Mobility Program) score T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41) 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.
QUEST-2 (Quebec User Evaluation of Satisfaction with Assistive Technology) questionnaire score T0 (day 2), T13 (day41) 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.
MSAQ (Motion Sickness Assessment Questionnaire) score T1 (day 3), T6 (day 25), T12 (day 40) 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.
IPQ (iGroupPresence Questionnaire) score T1 (day 3), T6 (day 25), T12 (day 40) 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).
NASA-TLX (NASA Task Load Index) score T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41) 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.
mNASA-TLX (modified NASA Task Load Index) score 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) 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.
GDQ (Game Design Questionnaire) score T1 (day 3), T6 (day 25), T12 (day 40) 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.
Trial Locations
- Locations (1)
IRCCS Istituto delle Scienze Neurologiche di Bologna
🇮🇹Bologna, Italy