The Role of Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients. A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Timed Up and Go (TUG) test
研究概览
简要总结
Multiple Sclerosis (MS) is often characterized by the presence of balance and cognitive impairments. Cognitive functions play a key role in balance control. Simultaneously performing cognitive tasks decreases walking and balance ability (Dual-Task cost). Rehabilitative treatment of patients with MS does not have to consider separately the motor and cognitive aspects. Video-Game Therapy (VGT) is a novel tool that allows a multimodal training approach. VGT typically provides augmented feedback during training that can contribute to learning motor skills. The main objective of this exploratory study will be to test the effects of a commercially available VGT on balance and cognitive function in ambulatory MS patients compared to a standardized balance platform training (BPT). Secondary, we will explore the effects of VGT and BPT on other domains that are usually impaired in MS population and that can be improved by motor rehabilitation, such as psychological well-being, fatigue and Quality of Life.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of MS (primary or secondary progressive, relapsing-remitting), without relapses in the preceding 3 months
- •mild to moderate balance impairments with increased fall risk, defined as TUG > 8.4s
- •disability rate definited by Kurtzke Expanded Disability Status Scale (EDSS) score from 4 to 5.5,
排除标准
- •other conditions that may affect motor function
- •impaired cognitive functioning (Mini Mental Status Examination score less than 24)
- •visual impairments (daltonism and visual acuity deficit)
- •medical conditions that might interfere with the ability to complete the study protocol safely.
- •A group of healthy subjects matched for age and sex will be involved for a comparison on the instrumental data (force platforms).
结局指标
主要结局
Timed Up and Go (TUG) test
时间窗: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
TUG measures balance and functional mobility.
次要结局
- Beck Depression Inventory-Second Edition (BDI-II)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Dynamic Gait Index (DGI)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Modified Fatigue Impact Scale (MFIS)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Multiple Sclerosis Walking Scale-12 (MSWS-12)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Multiple Sclerosis Impact Scale-29 (MSIS-29)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Go-No Go - Test of Attentional Performance T.A.P.(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Symbol Digit Modalities Test (SDMT)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Four Square Step Test (FSST)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Functional Reach Test (FRT)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Instrumented Basic Balance Evaluation (IBBE)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- State Trait Anxiety Inventory (STAI-Y)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Stroop Color-Word Test (SCWT)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Test of Attentional Performance T.A.P.(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
- Instrumented Dual Task (IDT)(Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up)
研究者
Sofia Straudi
MD
University Hospital of Ferrara