Virtual Reality for Gait Training in Multiple Sclerosis (VIRTUE): an Interventional Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Score of the standardized tests and gait parameters
研究概览
简要总结
This non-drug, non-medical device, interventional study explores the feasibility of integrating virtual reality (VR) with wearable sensors to support gait training using a passive orthosis in individuals with multiple sclerosis (MS). The aim is to determine whether this approach can enhance clinical gait assessment and facilitate orthosis adaptation by replicating real-life scenarios within a safe and controlled environment. The virtual environment, accessed through a head-mounted display, will be delivered via a custom simulator incorporating standardized gait tasks embedded in everyday settings. This system is designed to minimize the artificial influence of clinical settings on walking performance, while providing clinicians with objective gait data for more comprehensive evaluation.
详细描述
Patients with multiple sclerosis (MS) often experience significant gait impairments that impact their autonomy and overall quality of life. One of the primary rehabilitation strategies involves the use of walking braces. While these orthotic devices can support ambulation, their effective integration into daily life typically requires a period of adaptation and specific training. Traditionally, gait training and orthosis prescription occur in clinical settings, which may not fully reflect the real-world challenges that patients encounter. Moreover, current clinical assessments rely primarily on subjective observations and standardized scales, which may lack the sensitivity and objectivity needed to capture the full complexity of gait performance.
virtual reality (VR) offers a promising opportunity to simulate realistic walking environments in a controlled and safe setting, such as an outpatient clinic, potentially enhancing the outcomes of gait rehabilitation. Another promising technology in this domain is the use of wearable inertial sensors, which have been shown to effectively measure gait and postural parameters in people with MS. A further challenge associated with the use of orthotic devices is the physical and psychological stress they may cause, which can lead patients to discontinue their use. To evaluate such discomfort more objectively, recent studies have explored the use of physiological signal analysis and machine learning (ML) algorithms as an alternative or complement to self-reported questionnaires.
The integration of VR with wearable inertial and physiological sensors may allow for a more comprehensive and objective assessment of a patient's adaptation to walking braces. However, no validated system currently exists that combines these technologies for gait assessment and training with passive orthoses in people with MS.
The VIRTUE study aims to address this gap by developing and evaluating a VR-based platform (VIRTUE4MS) that replicates real-life scenarios, such as navigating through a museum, park, or grocery store, and enables standardized gait assessments within immersive environments. The system will employ both inertial and physiological wearable sensors to gather data on gait dynamics and user experience, ultimately supporting clinical decision-making regarding orthotic use. In this study, 12 patients with MS will perform walking and balance tasks over three sessions (T1, T2, T3), both with and without the Exoband brace, in VR and real-world conditions. Ultimately, this study seeks to explore an innovative, technology-supported approach to orthosis assessment and gait training that could complement traditional clinical tools and contribute to more effective, personalized rehabilitation strategies for individuals with MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of multiple sclerosis
- •Age between 18 and 65 years
- •Both sexes
- •Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS > 100)
- •Expanded Disability Status Scale (EDSS between 3 and 6 inclusive)
- •Berg Balance Scale (BBS ≥ 46)
- •Indication for the use of the Exoband orthosis for gait assistance
- •Modified Fatigue Impact Scale (MFIS) physical subscale ≤ 20
- •Signed informed consent
排除标准
- •Presence of severe or current visual or auditory impairments
- •Relapses within the last 3 months
- •Presence of severe anxiety or depression
- •Severe spasticity patterns in the lower limbs or fixed distal tendon contractures
- •Presence of motion sickness symptoms induced by virtual reality (VR)
结局指标
主要结局
Score of the standardized tests and gait parameters
时间窗: From T1 (day 2) to T2 (day 9)
This outcome assesses the adaptation to the walking brace during ambulation. Gait performance across different sessions will be analyzed and compared to observe improvement between T1 and T2. Participant satisfaction with the use of VR will be considered met if individuals can successfully engage with and complete the sessions using the system.
次要结局
- NASA-TLX (NASA Task Load Index) questionnaire score(T1 (day 2); T2 (day 10); T3 (day 70))
- MSAQ (Motion Sickness Assessment Questionnaire) questionnaire score(T0 (day 1); T1 (day 2); T2 (day 10))
- IPQ (iGroupPresence Questionnaire) questionnaire score(T1 (day 2); T2 (day 10))
- MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire score(T1 (day 2), T2 (day 10), T3 (day 70))
- BBS (Berg Balance Scale) questionnaire score(T1 (day 2); T2 (day 10); T3 (day 70))
- EDSS (Expanded Disability Status Scale) questionnaire score(T0 (day 1))
- MFIS (Modified Fatigue Impact Scale) questionnaire score(T0 (day 1); T1 (day 2); Th (day 3-9); T2 (day 10); T3 (day 70))
- TAM (Technology Acceptance Model) questionnaire score(T0 (day 1); T2 (day 10))
- MSWS-12 (Twelve-Item Multiple Sclerosis Walking Scale) questionnaire score(T1 (day 2); T2 (day 10); T3 (day 70))
- Timed 25-Foot Walk Test (T25FW) test score(T1 (day 2); T2 (day 10); T3 (day 70))
- 2MWT (2-Minute Walk Test) test score(T1 (day 2); T2 (day 10); T3 (day 70))
- TLSQ-WT (Tele-healthcare Satisfaction Questionnaire - Wearable Technology) questionnaire score(T2 (day 10))
- Timed Up and Go (TUG) test score(T1 (day 2); T2 (day 10); T3 (day 70))
