Development of Augmented Reality-Based Dual-Task Training to Enhance Cognitive and Motor Function in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gait Velocity- single-task (BTS GAITLAB)
研究概览
简要总结
Multiple Sclerosis (MS) is the most common NDD affecting young people worldwide. MS can seriously affect quality of life and hinder daily functional activities. Therefore, living with MS is a daunting task for both patients and their families. With the prediction of an increase in life expectancy, it is also expected that MS will pose major challenges to healthcare providers in the UAE and globally in terms of its clinical management and financial implications. This proposed project aims to develop structured AR scenarios that integrate dual-tasking exercises commonly used in MS physiotherapy, specifically designed to meet the needs of PwMS. The primary goal is to evaluate the feasibility, acceptability, and potential benefits of these AR scenarios as a rehabilitation tool for PwMS.
详细描述
Among the most concerning aspects of MS are the presence of gait impairments, balance deficits, and cognitive dysfunction. These symptoms become even more pronounced under dual-task conditions. Dual tasks require individuals to perform cognitive and motor tasks simultaneously. The interaction between cognitive and motor functions is vital for daily activities. Any disruption in this connection can lead to significant disabilities, including an increased risk of falls, which can severely impact a person's quality of life. However, despite the clear evidence that PwMS struggle with dual-tasking, there are limited therapeutic interventions that effectively utilize the dual-task paradigm to mitigate its consequences. A systematic review conducted by Plummer et al highlighted the impact of traditional physiotherapy dual-task training and the lack of cognitive-motor interaction in older adults, which limits the availability of evidence-based recommendations. The lack of dual task interaction in traditional physiotherapy approaches has been identified as a contributing factor to the suboptimal outcomes in improving mobility, cognitive function, and consequently the fall risks. The integration between cognitive-motor interaction in rehabilitation is crucial to achieve better outcomes to reduce fall risk. To address this gap, a rehabilitation program that specifically targets cognitive-motor interactions is warranted.
In the last few years, the use of gaming technology has emerged in the neurorehabilitation field with advancements in technology. Gaming technology provides subjects with task-oriented training, repetitive practice with high intensity, multi-sensory feedback information, and motivation for endurance practice. It offers a more accessible and cost-effective intervention compared to traditional physical therapy. However, few studies have investigated the effects of dual-task training using virtual reality (VR) in people with Multiple Sclerosis (PwMS). A recent systematic review (currently under review) found that VR dual-task training has shown weak effects. This may be due to previous studies utilizing generic VR games that were not tailored to the specific impairments associated with MS. Additionally, the immersive nature of VR may induce cyber sickness, causing discomfort similar to motion sickness.
In contrast to VR, Augmented Reality (AR) technology is emerging as a promising alternative in the field of rehabilitation. The use of AR in neurological rehabilitation has significantly expanded, offering a unique advantage by seamlessly combining motor and cognitive tasks. In AR, users interact with real environments enhanced by virtual objects relevant to daily activities, enabling effective motor-cognitive training with immediate feedback in a safe, controlled setting, crucial for improving rehabilitation outcomes. AR is also less overwhelming compared to other gaming technologies, as it does not provide a fully immersive experience, making it easier for patients who struggle with intense visual and sensory stimulation. Additionally, the flexibility of AR allows patients to engage in therapy at home, easily integrating it with everyday activities. This rehabilitation approach enhances the enjoyment of therapy, providing an interactive experience, which can improve long-term adherence, a vital factor for managing a progressive disease like MS, where maintaining function throughout all stages is essential. This project aims to support people with Long Term Neurological Conditions (LTNC) with complex needs as per MS to maintain mobility and cognitive function has potential to reduce dependence on residential services and acute hospital care. This proposed project also aligns with the National Multiple Sclerosis Society priorities and objectives which emphasize advancing innovative and emerging treatments that can slow and reverse MS. It has an important role to play in developing seamless programs for the management of people with LTNCs that focus on early intervention with better use of technology approaches in rehabilitation that can also form a sustainable resource to patient's self-management in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurologist-confirmed diagnosis of MS according to the revised McDonald criteria and PDDS score of ≤6
- •Age above 18 years;
- •Affected by relapsing remitting and secondary progressive MS
- •Successful completion of Physical Activity Readiness Questionnaire (PAR-Q)
- •Presence of mild/moderate cognitive impairment (Montreal Cognitive Assessment - MoCA >18)
- •Ambulatory for indoor and outdoor mobility with or without an assistive device but without physical assistance
排除标准
- •Acute illness or injury that would prevent safe participation in an exercise program
- •Presence of any other neurological conditions (e.g., stroke),
- •Presence of severe psychiatric illness other than anxiety or depression
- •According to the Diagnostic and Statistical Manual of Mental Disorders, 5th -Edition (DSM- V),
- •Presence of disabling sensory alterations (i.e. auditory and visual disturbances)
- •Relapse in the 3 months before enrollment
- •Current engagement in 3 days a week or more of moderate/vigorous exercise
研究组 & 干预措施
Home-based exercises
Home exercise control group will include the same exercises as in the intervention group except that they will perform at home for the same parameters without the utility of AR.
Augmented Reality
The participants in the experimental group will be asked to make 3 visits per week for a total of 18 sessions over the intervention period (6-week). Each session is expected to last between 40 minutes to one hour.
干预措施: Augmented Reality Exercises (Other)
结局指标
主要结局
Gait Velocity- single-task (BTS GAITLAB)
时间窗: six weeks
Measured using BTS GAITLAB (Physiotherapy Laboratory, University of Sharjah) during walking under single-task condition (walking only). Report mean gait velocity across trials. Higher = faster walking.
Gait velocity during dual-task walking (m/s)
时间窗: 6 weeks
Measured using BTS GAITLAB during walking under dual-task cognitive condition. Report mean gait velocity across trials. Higher = faster walking under dual-task.
次要结局
- Functional Mobility Scale (FMS) rating(6 weeks)
- Balance - Berg Balance Scale (BBS)(Six weeks)
- Activities-specific Balance Confidence (ABC) Scale score (0-100%)(6 weeks)
- Five Times Sit-to-Stand test time (seconds)(6 weeks)
- Biodex Balance System stability index (unit per device output)(6 weeks)
- Daily step count measured by FIBION (steps/day)(6 weeks)
- Modified Physical Activity Scale (M-PAS) score(6 weeks)
- Falls Efficacy Scale-International (FES-I) total score(6 weeks)
- Modified Fatigue Impact Scale (MFIS) total score(6 weeks)
- Short Form-36 (SF-36) health-related quality of life score(6 weeks)
- Hospital Anxiety and Depression Scale (HADS-A) score (0-21)(6 weeks)
- Hospital Anxiety and Depression Scale (HADS-D) score (0-21)(6 weeks)
- 6-Minute Walk Test distance (meters)(6 weeks)
- Montreal Cognitive Assessment (MoCA) total score (0-30)(6 weeks)
- Symbol Digit Modalities Test (SDMT) score (correct responses)(6 weeks)
- Hopkins Verbal Learning Test-II (HVLT-II) total recall score(6 weeks)
- Brief Visuospatial Memory Test-Revised (BVMT-R) total recall score(6 weeks)
- Stroop test interference score (per protocol)(6 weeks)
研究者
Alham Al-Sharman
Dr.
University of Sharjah
