Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Time to complete Timed Up and Go (TUG)
研究概览
简要总结
A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants receive training in both arms and will be blinded to the exercise group differences.
Outcomes assessor will be blinded to the group allocation and will carry out all assessments in a standardized manner irrespective Investigator will perform blinded analyses of the data
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 40 - 90 years of age
- •Have a diagnosis of Parkinson's disease
- •Be able to walk for 10 min without an aid
- •Be able to follow and understand the oral instructions of the investigator
- •Have a disease stage of I to IV (while ON-medication)
- •Have had no change in your Parkinson's medication in the past month (or to your deep brain stimulator if applicable) and also no planned changes in medication over the next 4 months
- •Have at least about 1 "freezing" episode per day (based on the New Freezing of Gait Questionnaire: N-FOG)
- •Not participating in another clinical trial
- •Have no acute joint disease
- •Not have any other condition that affects your walking pattern or prevents you from completing all study tasks
- •Have not undergone major surgery or hospitalization in the last 3 months
- •No substance abuse
- •No depressive disorder or other apathetic disorder that precludes daily exercise
排除标准
- 未提供
研究组 & 干预措施
SBT+CP
Split-belt training + complex task practice
干预措施: Complex task practice (Behavioral)
SBT+PL
Split-belt training + upper-limb exercise
干预措施: Split-belt treadmill training (Behavioral)
SBT+PL
Split-belt training + upper-limb exercise
干预措施: Upper-limb coordination and power (Behavioral)
SBT+CP
Split-belt training + complex task practice
干预措施: Split-belt treadmill training (Behavioral)
结局指标
主要结局
Time to complete Timed Up and Go (TUG)
时间窗: up to 8 weeks post intervention
Overall time to complete the Timed Up and Go task. The training is expected to improve multiple transitions between straight walking and turning and should be reflected in the overall task time.
Percentage Time Frozen during turning in place
时间窗: up to 8 weeks post intervention
Percentage Time Frozen scored from video of rapid alternating full turns in place. Based on earlier work showing immediate effects of SBT training on FOG during this task.
次要结局
- Percentage Time Frozen over all FOG-provoking tasks(up to 8 weeks post intervention)
- Percentage Time Frozen over 1-week free-living monitoring(up to 8 weeks post intervention)