Comparison of Two Home-based Gait and Balance Trainings With Different Training Frequencies in Patients With Parkinson's Disease and Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- gait velocity
研究概览
简要总结
The research project is an experimental study with three study visits at the study site at the University Hospital Düsseldorf (UKD) / Heinrich Heine University Düsseldorf (HHU) and a three-week training phase in a parallel design. Patients with movement disorders (ataxia or Parkinson's disease) can take part. The training phase includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. Two different training protocols are carried out in parallel for three weeks each: One with 20 minutes of training per day, four days per week; and one with a training duration of 40 minutes per day, only two days per week. All patients initially take part in a one-week familiarization phase without training and are then randomly assigned to one of the two training protocols or the control group without additional training. In both training phases, the total amount of weekly training time is the same, but the frequency and duration of training sessions per week differs. The patients who were assigned to the control group without additional training can complete the training after their third study visit.
详细描述
It will be investigated separately for the two patient groups (ataxia, Parkinsons disease), whether the video-based training can lead to an improvement in gait and balance and whether the training protocols differ with regard to the desired improvement. The gait and balance variables recorded using the two standard methods (force plate, motion capturing system) will serve as the basis for assessing the training effect. Furthermore, the investigators want to analyze how the individual variables differ between the healthy subjects (from our previous study) and patients with movement disorders.
Patients can also voluntarily record movement data using their own smartphone. This has the advantage that data can also be collected at home, which is more likely to reflect the everyday life of the participants. In particular, the aim is to check whether the data collected with the smartphone can also be read and analyzed in patients, despite the increased movement variability, and whether typical movement patterns and training-related changes can be recorded.
Only adults will take part in the study. The aim is to assess 21 patients with cerebellar ataxia or idiopathic Parkinsons disease per group. This number is based on a power calculation with the software G*Power 3.1.9.7 (Test family t tests, Means: Difference between two independent means (two groups)), with one-sided significance with α = 0.05, 1-β = 0.8 and a calculated effect size of 0.8. Participants in the study will be fully informed in advance about the study procedure. Participation in the study is voluntary. Participants can withdraw from the study at any time without giving reasons and without any disadvantages. A clinical diagnosis of cerebellar ataxia or idiopathic Parkinsons disease is a prerequisite for participation in the study. Participants must also be able to walk independently for 2 minutes. Exclusion criteria are other diseases with an impact on motor skills or serious primary psychiatric illnesses, current drug or alcohol dependency, consumptive illnesses or a poor general condition. There must be no increased risk of falling. Parkinsons patients should carry out the measurements on site and at home during the on-phase of the medication, approx. 2 hours after taking the medication. Patients are recruited via the special outpatient clinic for movement disorders at the Institute for Movement Disorders and Neuromodulation at the UKD / HHU Düsseldorf.
The study is discontinued for the individual study participant if an increased risk of falls becomes apparent. The study as a whole will be discontinued if it becomes apparent that the risks of the study outweigh the benefits or if unforeseen complications arise during the training 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 (Investigator)
盲法说明
The investigator who carries out the neurological examination after the training phase is blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of cerebellar ataxia or idiopathic Parkinson's syndrome
- •opportunity to walk a distance of four meters unhindered at home
排除标准
- •other diseases with an impact on motor skills
- •severe primary psychiatric illnesses
- •current drug or alcohol addiction
- •consumptive diseases
- •poor general condition
- •increased risk of falling (anamnestic fall frequency of ≥ 1x per week or as assessed by the attending physician)
- •incapacitated patients in official or court custody or patients unable to give consent
- •for PD patients taking medication: not being able to carry out the measurement in the on-phase of the medication
结局指标
主要结局
gait velocity
时间窗: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measured in m/s, measured by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).
次要结局
- stride time(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- step width(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- cadence(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- Lat Step Dev(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- Toe Out Angle(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- Double Support Time(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- Toe Off Angle(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- sway area(rom enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- sway velocity(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- trunk ROM(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- UPDRS score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- Hoehn and Yahr score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- SCAFI score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- sway path(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- arm-pelvis distance(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- foot elevation(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- FARS-ADL score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- EQ-5D-SL score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- TUG time(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- FAHW score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- ABC-D score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- MSWS-12(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- PDQ-39(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- PGIC(At the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
- SARA score(From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
研究者
Martina Minnerop, MD
Principal Investigator
Forschungszentrum Juelich