De Keersmaecker Emma, Guida Stefania, Denissen Stijn, Dewolf Luna, Nagels Guy, Jansen Bart, Beckwée David, Swinnen Eva
Faculty of Physical Education and Physiotherapy, Rehabilitation Research Group, Vrije Universiteit Brussel, Brussels, Belgium.
Unit of Clinical Epidemiology, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Cochrane Database Syst Rev. 2025 Jan 7;1(1):CD013834. doi: 10.1002/14651858.CD013834.pub2.
Multiple sclerosis (MS) is the most common neurological disease in young adults. Virtual reality (VR) offers a promising rehabilitation tool by providing controllable, personalised environments for safe, adaptable and engaging training. Virtual reality can be tailored to patients' motor and cognitive skills, enhancing motivation through exciting scenarios and feedback.
Primary objective To assess the effects of virtual reality interventions compared with an alternative or no intervention on lower limb and gait function, and balance and postural control in people with MS. Secondary objective To assess the effects of virtual reality interventions compared with an alternative or no intervention on upper limb function, cognitive function, fatigue, global motor function, activity limitation, participation restriction and quality of life, and adverse events in people with MS.
We identified relevant articles through electronic searches of CENTRAL, MEDLINE, Embase, PEDro, CINAHL and Scopus. We also searched trials registries (ClinicalTrials.gov and the WHO ICTRP search portal) and checked reference lists. We carried out all searches up until August 2022.
We included only (quasi-)randomised controlled trials (RCTs) that assessed virtual reality interventions, defined as "an artificial, computer-generated simulation or creation of a real-life environment or situation allowing the user to navigate through and interact with", in people with MS. The primary outcomes were lower limb and gait function, and balance and postural control. Secondary outcome measures were upper limb function, cognitive function, fatigue, global motor function, activity limitation, participation and quality of life, and adverse events. Eligible participants were people with MS who were 18 years or older.
Two review authors independently screened the studies based on pre-specified criteria, extracted study data and assessed the risk of bias of the included studies. We used the risk of bias 2 tool (RoB 2). A third review author was consulted to resolve conflicts.
We included 33 RCTs with 1294 people with MS. The sample sizes of the included studies were relatively small and there was considerable heterogeneity between studies regarding the virtual reality devices and the outcome measures used. The control group either received no intervention, conventional therapy or an alternative intervention (an intervention that does not fit the description of conventional therapy for the rehabilitation of people with MS). We most frequently judged the risk of bias as 'some concerns' across domains, leading to an overall high risk of bias in the majority of included studies for all outcome measures. Primary outcomes When compared with no intervention, virtual reality interventions may result in no difference in lower limb and gait function (Timed Up and Go, mean difference (MD) -0.43 sec, 95% confidence interval (CI) -0.85 to 0.00; 6 studies, 264 participants; low-certainty evidence) or balance and postural control (Berg Balance Scale, MD 0.29 points, 95% CI -0.1 to 0.68; 4 studies, 137 participants; very low-certainty evidence). When virtual reality interventions are compared to conventional therapy, results for lower limb and gait function probably do not differ between interventions (Timed Up and Go, MD -0.2 sec, -1.65 to 1.25; 4 studies, 107 participants; moderate-certainty evidence). However, virtual reality interventions probably improve balance and postural control (Berg Balance Scale, MD 2.39 points, 95% CI 1.22 to 3.57; 7 studies, 201 participants; moderate-certainty evidence), almost reaching the clinically important difference (3 points). Secondary outcomes Compared to no intervention, the use of virtual reality may also improve upper limb function (9-Hole Peg Test, MD -4.19 sec, 95% CI -5.86 to -2.52; 2 studies, 84 participants; low-certainty evidence), almost reaching the clinically important difference (4.38 points) and participation and quality of life, but the evidence is very uncertain (MS International QoL, MD 9.24 points, 95% CI 5.76 to 12.73; 2 studies, 82 participants; very low-certainty evidence). Compared to conventional therapy, virtual reality interventions may improve participation and quality of life (Falls Efficacy Scale-1, MD -3.07 points, 95% CI -5.99 to -0.15; 3 studies, 101 participants; low-certainty evidence), but not upper limb function (9-Hole Peg Test, MD 0.10 sec, 95% CI -1.70 to 1.89; 3 studies, 93 participants; low-certainty evidence). For other key secondary outcome measures, i.e. global motor function and adverse events, there were no data available as these were not measured in the studies.
AUTHORS' CONCLUSIONS: We found evidence that the use of virtual reality may be more effective than no intervention in improving upper limb function and participation and quality of life. Training with virtual reality may be superior to conventional therapy for improving balance and postural control, and participation and quality of life. For the other outcomes, there was no clear difference between virtual reality and conventional therapy. There was insufficient evidence to reach conclusions about the effect of virtual reality on global motor function, activity limitations and adverse events. Additional high-quality, large-scale studies are needed to expand and confirm these findings.
多发性硬化症（MS）是年轻成年人中最常见的神经疾病。虚拟现实（VR）通过提供可控的个性化环境，为安全、适应性强且引人入胜的训练提供了一种有前景的康复工具。虚拟现实可以根据患者的运动和认知技能进行定制，通过刺激的场景和反馈增强动机。
主要目的是评估与替代干预或无干预相比，虚拟现实干预对MS患者下肢和步态功能、平衡及姿势控制的影响。次要目的是评估与替代干预或无干预相比，虚拟现实干预对MS患者上肢功能、认知功能、疲劳、整体运动功能、活动受限、参与限制和生活质量以及不良事件的影响。
我们通过对CENTRAL、MEDLINE、Embase、PEDro、CINAHL和Scopus进行电子检索来识别相关文章。我们还检索了试验注册库（ClinicalTrials.gov和世界卫生组织国际临床试验注册平台搜索门户）并检查了参考文献列表。我们进行的所有检索截至2022年8月。
我们仅纳入了评估虚拟现实干预的（准）随机对照试验（RCT），虚拟现实干预被定义为“对现实生活环境或情况的人工、计算机生成的模拟或创建，允许用户在其中导航并与之交互”，研究对象为MS患者。主要结局是下肢和步态功能、平衡及姿势控制。次要结局指标是上肢功能、认知功能、疲劳、整体运动功能、活动受限、参与和生活质量以及不良事件。符合条件的参与者为18岁及以上的MS患者。
两位综述作者根据预先设定的标准独立筛选研究、提取研究数据并评估纳入研究的偏倚风险。我们使用了偏倚风险2工具（RoB 2）。如有冲突，会咨询第三位综述作者来解决。
我们纳入了33项RCT，涉及1294名MS患者。纳入研究的样本量相对较小，且在虚拟现实设备和所使用的结局指标方面，研究之间存在相当大的异质性。对照组要么未接受干预、接受传统疗法，要么接受替代干预（一种不符合MS患者康复传统疗法描述的干预）。我们在各个领域最常将偏倚风险判定为“有些担忧”，导致大多数纳入研究中所有结局指标的总体偏倚风险较高。主要结局与无干预相比，虚拟现实干预可能在下肢和步态功能方面无差异（计时起立行走测试，平均差（MD）-0.43秒，95%置信区间（CI）-0.85至0.00；6项研究，264名参与者；低确定性证据），或在平衡及姿势控制方面无差异（伯格平衡量表，MD 0.29分，95% CI -0.1至0.68；4项研究，137名参与者；极低确定性证据）。当将虚拟现实干预与传统疗法进行比较时，下肢和步态功能的结果在干预之间可能无差异（计时起立行走测试，MD -0.2秒，-1.65至1.25；4项研究，107名参与者；中等确定性证据）。然而，虚拟现实干预可能会改善平衡及姿势控制（伯格平衡量表，MD 2.39分，95% CI 1.22至3.57；7项研究，201名参与者；中等确定性证据），几乎达到临床重要差异（3分）。次要结局与无干预相比，使用虚拟现实还可能改善上肢功能（九孔插板测试，MD -4.19秒，95% CI -5.86至-2.52；2项研究，84名参与者；低确定性证据），几乎达到临床重要差异（4.38分）以及参与和生活质量，但证据非常不确定（MS国际生活质量量表，MD 9.24分，95% CI 5.76至12.73；2项研究，82名参与者；极低确定性证据）。与传统疗法相比，虚拟现实干预可能会改善参与和生活质量（跌倒效能量表-1，MD -3.07分，95% CI -5.99至-0.15；3项研究，101名参与者；低确定性证据），但不会改善上肢功能（九孔插板测试，MD 0.10秒，95% CI -1.70至1.89；3项研究，93名参与者；低确定性证据）。对于其他关键的次要结局指标，即整体运动功能和不良事件，由于这些在研究中未被测量，所以没有可用数据。
我们发现有证据表明，使用虚拟现实在改善上肢功能以及参与和生活质量方面可能比无干预更有效。虚拟现实训练在改善平衡及姿势控制以及参与和生活质量方面可能优于传统疗法。对于其他结局，虚拟现实与传统疗法之间没有明显差异。关于虚拟现实对整体运动功能、活动受限和不良事件的影响，没有足够的证据得出结论。需要更多高质量、大规模的研究来扩展和证实这些发现。
