Augmented Reality-Based Dual-Task Training in People With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented Reality Exercises.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Augmented Reality-Based Dual-Task Training to Enhance Cognitive and Motor Function in People With Multiple Sclerosis
Overview
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.
Detailed description
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.
Interventions
- Other Augmented Reality Exercises
All participants in the experimental group will then be given a tutorial on how to perform the proposed exercises based on AR and they will be asked to familiarise themselves with the system. While the participants in the control group will be given a leaflet of physical exercises and they will be instructed by a physical therapist on the correct performance of these exercises
Primary outcome measures
- Gait Velocity- single-task (BTS GAITLAB) [Time frame: six weeks]
- Gait velocity during dual-task walking (m/s) [Time frame: 6 weeks]
Secondary outcome measures (12)
- Balance - Berg Balance Scale (BBS) [Time frame: Six weeks]
- Activities-specific Balance Confidence (ABC) Scale score (0-100%) [Time frame: 6 weeks]
- Five Times Sit-to-Stand test time (seconds) [Time frame: 6 weeks]
- Functional Mobility Scale (FMS) rating [Time frame: 6 weeks]
- Biodex Balance System stability index (unit per device output) [Time frame: 6 weeks]
- Daily step count measured by FIBION (steps/day) [Time frame: 6 weeks]
- Modified Physical Activity Scale (M-PAS) score [Time frame: 6 weeks]
- Falls Efficacy Scale-International (FES-I) total score [Time frame: 6 weeks]
- Modified Fatigue Impact Scale (MFIS) total score [Time frame: 6 weeks]
- Short Form-36 (SF-36) health-related quality of life score [Time frame: 6 weeks]
- Hospital Anxiety and Depression Scale (HADS-A) score (0-21) [Time frame: 6 weeks]
- Hospital Anxiety and Depression Scale (HADS-D) score (0-21) [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United Arab Emirates · 1 center
- Alham Al Sharman — Sharjah city
Identifiers
NCT: NCT07434934 · REC-24-12-22-01-F · 133128