Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in the Modified Dynamic Gait Index
研究概览
简要总结
Balance and gait problems in subjects with neurological disease lead to reduced mobility, loss of independence and frequent falls. Treadmill training is a widely used form of treatment and it has been used in subjects with neurological disease to ameliorate walking and balance deficits. The Virtual Reality Treadmill as a therapeutic tool has been recently introduced to practice gait adaptability elicited by aligning foot placement relative to the projected visual context.
Forty-eight subjects with neurological disease will receive treadmill training treatment randomly divided in Traditional Treadmill training and Virtual Reality Treadmill training.
The aim of this randomized controlled study is to assess whether Treadmill training with Virtual Reality is better than Traditional Treadmill training in improving dynamic balance and cognitive aspects in subjects with neurological diseases.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Multiple Sclerosis (no relapse within the previous three months;), Parkinsons Disease (Hoenhn and Yahr Scale ≤4), Stroke (Time from onset >2 months)
- •Able to walk 20 meters with or without assistive device
- •Cognitive impairment (MMSE score ≥ 21)
排除标准
- •Unable to understand the aim of the study and unable to sign the informed consent
- •Steroidal drugs therapy for subjects with Multiple Sclerosis
- •Subjects with Psychiatric disorders
- •Subjects with Visual impairments
- •Subjects with cardiovascular disease
研究组 & 干预措施
Treadmill Training
40' treadmill training walking holding the handrail
干预措施: Treadmill training (Device)
Virtual Reality Treadmill Training
40' treadmill training walking with virtual visual and auditory cues
干预措施: Virtual Reality Treadmill Training (Device)
结局指标
主要结局
Change in the Modified Dynamic Gait Index
时间窗: Change from Baseline Modified Dynamic Gait Index scores at 3-5 weeks
Tool used to assess dynamic balance
Change in the 6 minutes walking test
时间窗: Change from Baseline 6 minutes walking test scores at 3-5 weeks
tool used to assess walking endurance
次要结局
- Change in 10-meter walking test(Change from Baseline10-meter walking test scores at 3-5 weeks)
- Change in Raven's Matrices(Change from Baseline Raven's Matrices scores at 3-5 weeks)
- Change in Activity Balance Confidence(Change from Baseline Activity Balance Confidence scores at 3-5 weeks)
- Change in Trial Making test(Change from Baseline Trial Making test scores at 3-5 weeks)
研究者
Davide Cattaneo
Research Coordinator, LaRiCE Lab, PhD
Fondazione Don Carlo Gnocchi Onlus