Viewing Study NCT06586125



Ignite Creation Date: 2024-10-26 @ 3:39 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06586125
Status: RECRUITING
Last Update Posted: None
First Post: 2024-06-28

Brief Title: Virtual Reality Impact on Powered Mobility a Feasibility Study
Sponsor: None
Organization: None

Study Overview

Official Title: The Impact of Virtual Reality on Powered Mobility in Patients with Neuromotor Disabilities a Feasibility Study
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VR-PMP
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 users39 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None