Steps Against the Burden of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Gait speed - T0
研究概览
简要总结
Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Treadmill training, augmented by mechanical/virtual-reality triggers, has proven effective in enhancing gait and reducing falls. However, underlying treadmill training mechanisms are unclear. To personalize training, we'll explore how PD patients benefit and transfer effects to daily life.
This trial is part of three parallel randomized controlled trials within the Steps Against the Burden of Parkinson's Disease (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004) project, which will perform a pooled analysis across all sites in addition to individual RCT analyses. Each trial adheres to a shared core protocol while allowing for adaptations in the perturbation protocol, ensuring that data can be combined. Importantly, mechanistic findings and outcomes from this specific RCT will be reported independently, but also as part of a pooled analysis.
In this trials, PD patients will undergo treadmill training with and without adaptations (perturbations). 12 sessions of treadmill training will be provided, with pre/post assessments and a Follow-up 12±2 weeks following T1 with pre/post assessments and a Follow-up 12±2 weeks following T1 at 8 to 12 weeks after the post assessment. For post treadmill training a phone app will be offered as a home-based speed dependent walk training intervention. This intervention is an App based training for gait adaptability and allows users to set their own training time and pace. It delivers a rhythmic metronomic beat for three different walking speeds, designed to trigger movement and encourage better walking patterns. Gait improvements are expected, driven by sensorimotor integration improving balance control. Biomechanical data analysis will reveal enhanced foot placement control. Neurophysiological changes will be studied through EEG and EMG, aiming to find improved gait stability with reduced EEG beta power and increased EEG-EMG coherence.
Gait improvement in the lab might not correlate with daily-life results. Gait self-efficacy could influence transfer, prompting investigation into mechanistic associations with mobility outcomes. Remote digital tools will assess week-long mobility outcomes, employing machine learning to comprehend why some improve both in lab and life, while others don't. This will uncover mechanisms translating treatment effects into real-world outcomes, aiding personalized intervention development.
详细描述
i. Rationale The rationale of this trial is that speed dependent treadmill training (SDTT) improves gait through improved sensorimotor integration, with changes in cortical activity as neural correlates. Additional benefits of treadmill training can be seen if perturbation or adaptations are added. This is based on the idea, that in addition to the sensorimotor integration the reactive balance in trained as well18. Furthermore, it hypothesizes that treadmill training and its effects on gait quality will improve gait self-efficacy, which mediates and/or modifies transfer of training effects to improved daily-life gait.
ii. Objectives
Thus, the objectives of our StepuP project are:
- To understand the kinematic and neural mechanisms that underlie improvements in gait due to treadmill training with and without mechanically and VR-triggered gait adaptations in people with PD;
- To assess to what extent improvements in gait due to treadmill training, as measured in the lab, transfer to improvements in daily life mobility;
- To understand the mechanisms that underpin transfer from improvements in gait to improvements of mobility in daily life in people with PD;
- To understand for whom treadmill training improves lab-based gait characteristics and for whom it does not, and understand for whom treadmill training improves mobility in daily life and for whom it does not.
Attaining these objectives will provide a better understanding of the successes and failures of treadmill training to improve gait stability and prevent falls in people with PD at an individual level, which in the medium term will allow targeted delivery of such interventions and in the long term will allow personalization of such interventions to improve outcomes for all.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PD according to the MDS Criteria
- •Hoehn and Yahr stages I to III;
- •Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more
- •Signed informed consent to participation
排除标准
- •Any known general health condition likely to interfere with or to pose a contraindication to non-medically supervised physical exercise.
- •Moderate or severe depression (BDI-II ≥18)
- •Cognitive impairment which may preclude the possibility to provide a fully informed consent to enrolment.
- •Linguistic comprehension capacity less than 75% in ordinary conversation
- •Severe psychiatric comorbidity which may interfere with compliance to the study protocol
- •History of or current status of substance dependency
- •Unable to walk less than 1 floor
- •Thoracic pain in the last 4 weeks
- •Currently enrolled in other interventional studies
- •Implanted Deep Brain Stimulation device
结局指标
主要结局
Gait speed - T0
时间窗: Baseline
Comfortable walking speed overground
Gait speed - T1
时间窗: After Intervention (2-12 weeks)
Comfortable walking speed overground
Gait speed - T2
时间窗: After Follow-up 12±2 weeks following T1 (20-32 weeks)
Comfortable walking speed overground
次要结局
- Changes in attitudes towards physical activity (Exercise Self-Efficacy Scale) - T2(Follow-up 12±2 weeks following T1)
- Exit interviews (Barriers and enablers to long-term use) - T1(After Intervention (2-12 weeks))
- Exit interviews (Barriers and enablers to long-term use) - T2(Follow-up 12±2 weeks following T1)
- Fall events (occurrence and frequency) and fall related injuries - T0(Baseline (T0))
- Fracture history - T0(Baseline (T0))
- Medication - T0(Baseline (T0))
- Medication - T1(After Intervention (2-12 weeks))
- Medication - T2(Follow-up 12±2 weeks following T1)
- Euro-Quality of life (EQ-5D) - T0(Baseline (T0))
- Euro-Quality of life (EQ-5D) - T1(After Intervention (2-12 weeks))
- Euro-Quality of life (EQ-5D) - T2(Follow-up 12±2 weeks following T1)
- Frailty Index (FI) - T0(Baseline (T0))
- Frailty Index (FI) - T1(After Intervention (2-12 weeks))
- Frailty Index (FI) - T2(Follow-up 12±2 weeks following T1)
- Kinematics: 3D motion capture data - T1(After Intervention (2-12 weeks))
- Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T0(Baseline (T0))
- Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T1(After Intervention (2-12 weeks))
- Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T2(Follow-up 12±2 weeks following T1)
- Kinematics: 3D motion capture data - T0(Baseline)
- Kinematics: 3D motion capture data - T2(Follow-up 12±2 weeks following T1)
- Electroencephalography (EEG) - T0(Baseline)
- Electroencephalography (EEG) - T1(After Intervention (2-12 weeks))
- Electroencephalography (EEG) - T2(Follow-up 12±2 weeks following T1)
- Electromyography (EMG) - T0(Baseline)
- Electromyography (EMG) - T1(After Intervention (2-12 weeks))
- Electromyography (EMG) - T2(Follow-up 12±2 weeks following T1)
- Gait speed (Preferred and maximal) - T0(Baseline)
- Gait speed (Preferred and maximal) - T1(After Intervention (2-12 weeks))
- Gait speed (Preferred and maximal) - T2(Follow-up 12±2 weeks following T1)
- Use of mobility aids - T0(Baseline)
- Use of mobility aids - T2(Follow-up 12±2 weeks following T1)
- Timed Up and Go (TUG) - T0(Baseline)
- Timed Up and Go (TUG) - T1(After Intervention (2-12 weeks))
- Timed Up and Go (TUG) - T2(Follow-up 12±2 weeks following T1)
- Two-minute walking test (2MWT) - T0(Baseline)
- Two-minute walking test (2MWT) - T1(After Intervention (2-12 weeks))
- Two-minute walking test (2MWT) - T2(Follow-up 12±2 weeks following T1)
- Mini-BESTest - T0(Baseline)
- Mini-BESTest - T1(After Intervention (2-12 weeks))
- Mini-BESTest - T2(Follow-up 12±2 weeks following T1)
- Modified Gait Efficacy Scale (mGES) - T0(Baseline)
- Modified Gait Efficacy Scale (mGES) - T1(After Intervention (2-12 weeks))
- Modified Gait Efficacy Scale (mGES) - T2(Follow-up 12±2 weeks following T1)
- Hand grip strength - T0(Baseline)
- Short Falls Efficacy Scale International (Short FES-i) - T0(Baseline)
- Short Falls Efficacy Scale International (Short FES-i) - T1(After Intervention (2-12 weeks))
- Short Falls Efficacy Scale International (Short FES-i) - T2(Follow-up 12±2 weeks following T1)
- Montreal Cognitive Assessment (MoCA) - T0(Baseline)
- Montreal Cognitive Assessment (MoCA) - T2(Follow-up 12±2 weeks following T1)
- Color Trail Test (CTT) - T0(Baseline)
- Color Trail Test (CTT) - T2(Follow-up 12±2 weeks following T1)
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T0(Baseline)
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T1(After Intervention (2-12 weeks))
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T2(Follow-up 12±2 weeks following T1)
- New Freezing of Gait Questionnaire (NFOGQ) - T0(Baseline)
- New Freezing of Gait Questionnaire (NFOGQ) - T1(After Intervention (2-12 weeks))
- New Freezing of Gait Questionnaire (NFOGQ) - T2(Follow-up 12±2 weeks following T1)
- Home assessment: Steps per day - T0(Baseline (T0))
- Home assessment: Steps per day - T1(After Intervention (2-12 weeks))
- Home assessment: Steps per day - T2(Follow-up 12±2 weeks following T1)
- Home assessment: Amount and length of uninterrupted walk durations - T0(Baseline (T0))
- Home assessment: Amount and length of uninterrupted walk durations - T1(After Intervention (2-12 weeks))
- Home assessment: Amount and length of uninterrupted walk durations - T2(Follow-up 12±2 weeks following T1)
- Home assessment: Stride time variability - T0(Baseline (T0))
- Home assessment: Stride time variability - T1(After Intervention (2-12 weeks))
- Home assessment: Stride time variability - T2(Follow-up 12±2 weeks following T1)
- Home assessment: Symmetry of gait - T0(Baseline (T0))
- Home assessment: Symmetry of gait - T1(After Intervention (2-12 weeks))
- Home assessment: Symmetry of gait - T2(Follow-up 12±2 weeks following T1)
- Home assessment: FOG episodes, Medication, and Physical activity (self-reports) - T0(Baseline (T0))
- Home assessment: FOG episodes, Medication, and Physical activity (self-reports) - T1(After Intervention (2-12 weeks))
- Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T0(Baseline (T0))
- Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T1(After Intervention (2-12 weeks))
- Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T2(Follow-up 12±2 weeks following T1)
- Acceptability and satisfaction with the intervention (System Usability Scale and PACES) - T1(After Intervention (2-12 weeks))
- Acceptability and satisfaction with the intervention (System Usability Scale and PACES) - T2(Follow-up 12±2 weeks following T1)
- Changes in attitudes towards physical activity (Exercise Self-Efficacy Scale) - T1(After Intervention (2-12 weeks))
研究者
Walter Maetzler
Prof. Dr.
University of Kiel