A Novel Training Method to Reduce Fall Risk in People With Parkinson's Disease: The Role of the Balance Organ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from baseline in stride time after 6 weeks training
研究概览
简要总结
Falls during walking are common in people with Parkinson's Disease (PD). Fall risk can be attributed in part to the loss of automaticity in walking and an increased reliance on sensory cues, such as the input from the balance organ. In this project the investigators want to assess the effectiveness of rehabilitation training aiming to improve this vestibular input. The effects of a visual perturbation training in a virtual reality environment will be compared to conventional treadmill training.
详细描述
Fifty participants (50-65 years) with idiopathic PD (Hoehn & Yahr scale 2-3) will be randomly assigned to the intervention group receiving four weeks of VPT in a VR environment using the Gait Real-time Analysis Interactive Lab system (GRAIL) or a control group receiving four weeks of regular treadmill training. Primary outcome measures are spatio-temporal outcome parameters of gait and dynamic stability (gait speed, stride time/length, cadence, step-to-step variability, step width variability and trunk sway), and self-reported falls, and will be recorded at all testing phases (pre-test, after baseline, after intervention and after detraining). Secondary outcome measures will include assessments of central and peripheral vestibular function (Cervical and ocular Vestibular Evoked Myogenic Potentials) for correlation with the primary outcome measures. The secondary outcomes will be recorded at pre-testing and directly after the intervention phase.
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 (Participant)
盲法说明
Participants will not be informed if they are allocated to the experimental intervention or the control 'sham' intervention.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease
- •Aged between 50-65 years
- •Bilateral symptoms
- •Able to walk unassisted for 20 minutes (Hoehn & Yahr stage II-III)
- •Stable medication dosage (if any)
- •No cognitive disablity
排除标准
- •Non-idiopathic Parkinson's disease
- •Strong variation in expressed symptoms
- •Inability to walk unassisted for 20 minutes
- •Underwent a medical procedure to treat Parkinson symptoms (e.g. duodopa pump, deep brain stimulator)
- •Cognitive disability (score < 21 on the Montreal Cognitive Assessment)
- •Illness other than Parkinson's disease (flu, Covid-19) or disabilities that may affect gait or equilibrium
- •Clogged ear(s)
- •Regular fainting episodes
- •Weight over 120 kg
- •Participation in other clinical studies
结局指标
主要结局
Change from baseline in stride time after 6 weeks training
时间窗: Week 1 to week 6 of training intervention
Delta in average duration (+variability) of a single step in ms
Change from baseline in step width after 6 weeks training
时间窗: Week 1 to week 6 of training intervention
Delta in average width(+variability) of a single step in cm
Change from baseline in gait speed after 6 weeks training
时间窗: Week 1 to week 6 of training intervention
Delta in average gait speed in m/s
Change from baseline in cadence after 6 weeks training
时间窗: Week 1 to week 6 of training intervention
Delta in steps per minute
Change from baseline in step length after 6 weeks training
时间窗: Week 1 to week 6 of training intervention
Delta in average length (+variability) of a single step in cm
Change from baseline in trunk sway after 6 weeks training
时间窗: Week 1 to week 6 of training intervention
Delta in medio-lateral and anterior-posterior movement of the center of mass as determined using 3D motion capturing in cm
次要结局
- Assessments of central and peripheral vestibular function(Post-test within 1 week after conclusion of the training intervention)
- Self-reported falls(Monthly up to six months after last training)