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临床试验/NCT06586125
NCT06586125已完成不适用

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

Azienda Usl di Bologna1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Number of dropout participants unable to use the VR-PMP simulator

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Number of dropout participants unable to use the VR-PMP simulator

时间窗: 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.

次要结局

  • PMP (Powered Mobility Program) score(T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41))
  • QUEST-2 (Quebec User Evaluation of Satisfaction with Assistive Technology) questionnaire score(T0 (day 2), T13 (day41))
  • MSAQ (Motion Sickness Assessment Questionnaire) score(T1 (day 3), T6 (day 25), T12 (day 40))
  • IPQ (iGroupPresence Questionnaire) score(T1 (day 3), T6 (day 25), T12 (day 40))
  • NASA-TLX (NASA Task Load Index) score(T0 (day 2), T1 (day 3), T6 (day 25), T12 (day 40), T13 (day 41))
  • 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))
  • GDQ (Game Design Questionnaire) score(T1 (day 3), T6 (day 25), T12 (day 40))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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