Innovative Low-cost Solutions Based on Virtual Reality for Upper Limb Home-based Rehabilitation in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in box and block score
研究概览
简要总结
This study is aimed to test the efficacy and feasibility of an immersive virtual reality (VR) rehabilitation programs to improve upper-limb motor functions in 24 patients with multiple sclerosis (pwMS), characterized by moderate to severe upper-limb motor dysfunctions. In particular, this study will evaluate the efficacy of VR as novel opportunities to increase treatment engagement and rehabilitation effects.
The effectiveness of the rehabilitation program will be assessed using both clinical tests and state-of-the art motion capture system for human movement analysis.
详细描述
Recent studies highlighted the high social and economic burden of rehabilitation in multiple sclerosis (MS); in fact its cost is approximately 27% of the overall expenses supported by the national health system. In particular, it has been shown that the physical rehabilitation is effective in treating functional impairments associated to gait, balance and daily life activitites. However, most rehabilitative treatments are performed at hospital or in specialized centers, and this is a factor which strongly reduces the persistence of the positive effects in the long-term.
In this context, it appears important to highlight that rehabilitative treatments are often focused on lower limbs functional impairments, while upper limbs dysfunctions seem less considered although approximately 50% of pwMS complain about issues like reduction of manual dexterity and fine motor abilities as well as movements' slowness. Moreover, significantly lower is also the number of the studies focused on upper limbs rehabilitation, if compared to those about walking or balance and also if compared with upper limbs studies in other neurologic diseases like stroke.
A support in overcoming such issues might be provided by the adoption of low-cost devices originally designed for entertainment purposes (e.g. Nintendo Wii or Microsoft Kinect) which have been shown effective in improving some aspects of disability. Nevertheless, while rehabilitation protocols which make use of such system often relies on software designed for healthy individuals, it should be essential to have available routines specifically designed for the MS needs.
On the basis of these considerations, this project intends to design, develop and test an innovative low-cost hardware/software platform for home-based upper limbs rehabilitation based on virtual reality.
In particular, the software will reproduce scenarios of actual daily living activities with increasing complexity to ensure a good degree of transferability of the training into real life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18
- •Definite MS diagnosis, sub-type Relapsing-Remitting or Secondary Progressive
- •Clinically stable
- •No relapses at the time of the enrolment in the study
- •Able to understand the informed consent process and provide consent to participate in the study
- •9-Hole Peg Test score > 30 seconds
排除标准
- •Relapses occurring over the past 3 months
- •History of seizures
- •Severe blurred vision
- •Concomitant auditory and vestibular deficits
- •Presence of other neurological, orthopaedic (non-MS related), psychiatric or cognitive impairments that would interfere with the execution of the study
研究组 & 干预措施
Virtual reality intervention
Participant undergo 12 treatment sessions, during a 4-week period (3 sessions per week).
Each intervention session lasts 45 minutes.
干预措施: Virtual Reality (Behavioral)
Observational
Participant undergo a 4 weeks observational period. No intervention are performed.
结局指标
主要结局
Change in box and block score
时间窗: Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)
The Box and Block Test measures unilateral gross manual dexterity. Score consists of the number of blocks transferred from one compartment to the other compartment in 60 seconds (score each hand separately). Higher values indicate better performance. Reference value for unaffected population is 55 blocks/min.
次要结局
- Change in Nine-Hole Peg score(Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2))
研究者
Massimiliano Pau
Associate Professor, Head of the
University of Cagliari