Augmented Reality Treadmill Training in Patients With Parkinson's Disease: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Frequency of falls
研究概览
简要总结
Gait disorder is a disabling symptom in Parkinson's disease (PD) affecting all patients during the course. Three methods of treadmill training (TT) will be compared to assess additional augmented reality (AR), or additional dual task (DT). AR TT, DT TT, and TT alone applied over 3 weeks at each day will be compared for their impact on falls, walking, freezing and attention for 3 months in a double blinded randomized controlled trial during regular neurorehabilitation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Parkinson´s disease without dementia and hallucination
- •at least one fall within the past 3 months or postural instability
- •Gait disorder
- •Hoehn and Yahr stages II-IV
- •able to perform the treadmill therapy during a study
排除标准
- •Contraindications to treadmill therapy (e.g. hip fracture)
- •Dementia as defined by an Montreal cognitive assessment (MOCA) < 20
研究组 & 干预措施
treadmill training with augmented reality dual tasking
干预措施: C-Mill augmented reality treadmill training (Device)
treadmill training with random number generation dual tasking
干预措施: C-Mill augmented reality treadmill training (Device)
treadmill training
干预措施: C-Mill augmented reality treadmill training (Device)
结局指标
主要结局
Frequency of falls
时间窗: 3 months before study to 3 months following the study
group difference of the difference in falls
次要结局
- Secondary outcomes:(before and after the training period of 3 weeks)
- Sensor based gait analyses(before and after the training period of 3 weeks and after 3 months)
研究者
Veit Mylius
Priniciple Investigator
Klinik Valens