A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walking Automaticity in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Minutes of Moderate Intensity Walking
研究概览
简要总结
The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program using a digital music-based device designed for self-directed gait training in people with Parkinson disease (PD). The study uses music cues delivered through this digital device to improve walking outcomes. The investigators want to know if personalized music cueing through the digital device can improve walking quality, walking ability, daily walking amount and intensity, and quality of life, while helping walking feel more automatic and require less mental effort. Participants will take part in this research study for approximately 18 weeks in total. During this time, participants will complete 4 study visits at designated research centers at Boston University, Washington University in St. Louis, or the University of Utah, depending on the site of enrollment.
详细描述
The overall goal of this single-arm, multi-center repeated baselines study (N=162) is to examine how a personalized closed-loop music-based digital gait intervention, using MR-005 (MedRhythms, Inc.), improves gait quality, capacity, real-world walking performance, and gait automaticity in Parkinson disease (PD). Participants will complete a community-based, self-directed walking program using the digital music-based device 4 days a week for 12 weeks, designed to promote sustained walking beyond the use of the device.
This study builds on a stepwise investigation beginning with a proof-of-concept feasibility study (N=23) followed by a 6-week randomized controlled trial (RCT; N=44). This mechanistic-focused study will examine the substrates of a personalized approach that underlie changes in walking outcomes, as well as identify determinants that determine responsiveness to the intervention. This study is a critical next step to elucidate mechanistic understanding of closed-loop personalized gait approaches and to determine those with PD who benefit most.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-report of diagnosis of typical Parkinson disease determined by a medical doctor
- •≥ 40 years of age
- •Community-dwelling (e.g. home, independent living, senior housing)
- •Have stable PD medications for at least two weeks prior to enrollment
- •Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist
- •Able to walk independently without physical assistance for at least 10 minutes (assistive devices allowed with reciprocal gait pattern)
- •Willing and able to provide informed consent
- •Provide HIPAA Authorization to allow communication with the primary healthcare provider for communication (as needed) during the study period
排除标准
- •< 40 years of age
- •Diagnosis of atypical Parkinsonism
- •Modified Hoehn and Yahr stages 4-5
- •Significantly disturbing freezing episodes during daily walking based on the New Freezing of Gait Questionnaire (Part III Item 7)
- •Fall frequencies >1x/week on average, over the past month.
- •Currently participating in physical therapy for Parkinson gait rehabilitation
- •Currently performing walking exercise at moderate intensities or higher for at least 30 min. per session ≥ 3x/week
- •Self-reported cardiac problems that interfere with the ability to safely exercise (e.g., congestive heart failure, uncontrolled cardiac arrhythmias, chest pain;
- •Orthopedic problems in the lower extremities or spine that may limit walking distance (e.g., severe arthritis, spinal stenosis, or significant pain)
- •Any other medical conditions that would preclude successful participation as determined by the researcher/ physical therapist
- •Cognitive impairment (i.e., Montreal Cognitive Assessment, MoCA < 21)
- •Unable to walk independently (i.e., without physical assistance) at a comfortable speed ≥ 0.4m/s as measured using the 10-meter Walk Test (10mWT) as examined in Baseline #1
- •Resting tachycardia (> 100 beats/min) or uncontrolled blood pressure (resting systolic BP > 160 mmHg or diastolic BP >100 mmHg)) as measured by the researcher/ physical therapist
- •Unable to independently use the music-based digital therapeutic during training
- •Significant hearing impairment
研究组 & 干预措施
MyMusiQ (MMQ) Walking intervention
Participants use MR-005 (MedRhythms, Inc., Portland, ME) during self-directed, home/community-based walking for 12 weeks to improve walking outcomes.
干预措施: MR-005 (MedRhythms, Inc., Portland, ME) (Device)
结局指标
主要结局
Minutes of Moderate Intensity Walking
时间窗: Baseline 1
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.
Minutes of Moderate Intensity Walking
时间窗: Baseline 2 (2-3 weeks after Baseline 1)
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.
Minutes of Moderate Intensity Walking
时间窗: Immediately after the intervention (about 3 months)
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.
Gait Speed
时间窗: Baseline 2 (2-3 weeks after Baseline 1)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Minutes of Moderate Intensity Walking
时间窗: Follow-Up (about 1 month post-intervention)
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.
Daily Step Counts
时间窗: Baseline 1
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
Daily Step Counts
时间窗: Baseline 2 (2-3 weeks after Baseline 1)
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
Daily Step Counts
时间窗: Immediately after the intervention (about 3 months)
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
Daily Step Counts
时间窗: Follow-Up (about 1 month post-intervention)
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
6-Minute Walk Test
时间窗: Baseline 1
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
6-Minute Walk Test
时间窗: Baseline 2 (2-3 weeks after Baseline 1)
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
6-Minute Walk Test
时间窗: Immediately after the intervention (about 3 months)
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
6-Minute Walk Test
时间窗: Follow-Up (about 1 month post-intervention)
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
Gait Speed
时间窗: Baseline 1
Gait speed (m/s) will be measured using research-grade wearable sensors.
Gait Speed
时间窗: Immediately after the intervention (about 3 months)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Gait Speed
时间窗: Follow-Up (about 1 month post-intervention)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Stride Length
时间窗: Baseline 1
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Stride Length
时间窗: Baseline 2 (2-3 weeks after Baseline 1)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Stride Length
时间窗: Immediately after the intervention (about 3 months)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Stride Length
时间窗: Follow-Up (about 1 month post-intervention)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Variability of Stride Time
时间窗: Baseline 1
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
Variability of Stride Time
时间窗: Baseline 2 (2-3 weeks after Baseline 1)
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
Variability of Stride Time
时间窗: Immediately after the intervention (about 3 months)
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
Variability of Stride Time
时间窗: Follow-Up (about 1 month post-intervention)
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
次要结局
- 10-Meter Walk Test (10MWT) - Comfortable Walking Speed(Baseline 1)
- 10-Meter Walk Test (10MWT) - Comfortable Walking Speed(Baseline 2 (2-3 weeks after Baseline 1))
- 10-Meter Walk Test (10MWT) - Comfortable Walking Speed(Immediately after the intervention (about 3 months))
- 10-Meter Walk Test (10MWT) - Comfortable Walking Speed(Follow-Up (about 1 month post-intervention))
- 10-Meter Walk Test (10MWT) - Fast Walking Speed(Baseline 1)
- 10-Meter Walk Test (10MWT) - Fast Walking Speed(Baseline 2 (2-3 weeks after Baseline 1))
- 10-Meter Walk Test (10MWT) - Fast Walking Speed(Immediately after the intervention (about 3 months))
- 10-Meter Walk Test (10MWT) - Fast Walking Speed(Follow-Up (about 1 month post-intervention))
- Five Times Sit-to-Stand(Baseline 1)
- Five Times Sit-to-Stand(Baseline 2 (2-3 weeks after Baseline 1))
- Five Times Sit-to-Stand(Immediately after the intervention (about 3 months))
- Five Times Sit-to-Stand(Follow-Up (about 1 month post-intervention))
- Generic Walking Scale (Walk-12G)(Baseline 1)
- Generic Walking Scale (Walk-12G)(Baseline 2 (2-3 weeks after Baseline 1))
- Generic Walking Scale (Walk-12G)(Immediately after the intervention (about 3 months))
- Generic Walking Scale (Walk-12G)(Follow-Up (about 1 month post-intervention))
- Global Rating of Change (GROC) Scale(Immediately after the intervention (about 3 months))
- Mini Balance Evaluation Systems Test (Mini-BESTest)(Baseline 1)
- Mini Balance Evaluation Systems Test (Mini-BESTest)(Baseline 2 (2-3 weeks after Baseline 1))
- Mini Balance Evaluation Systems Test (Mini-BESTest)(Immediately after the intervention (about 3 months))
- Mini Balance Evaluation Systems Test (Mini-BESTest)(Follow-Up (about 1 month post-intervention))
- Prefrontal Cortex Activity(Baseline 1)
- Prefrontal Cortex Activity(Baseline 2 (2-3 weeks after Baseline 1))
- Prefrontal Cortex Activity(Immediately after the intervention (about 3 months))
- Dual-Task Cost on Gait Speed(Baseline 1)
- Dual-Task Cost on Gait Speed(Baseline 2 (2-3 weeks after Baseline 1))
- Dual-Task Cost on Gait Speed(Follow-Up (about 1 month post-intervention))
- Dual-Task Cost on Gait Speed(Immediately after the intervention (about 3 months))
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)(Baseline 1)
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)(Baseline 2 (2-3 weeks after Baseline 1))
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)(Immediately after the intervention (about 3 months))
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)(Follow-Up (about 1 month post-intervention))
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)(Baseline 1)
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)(Baseline 2 (2-3 weeks after Baseline 1))
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)(Follow-Up (about 1 month post-intervention))
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)(Immediately after the intervention (about 3 months))
- Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)(Baseline 1)
- Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)(Baseline 2 (2-3 weeks after Baseline 1))
- Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)(Immediately after the intervention (about 3 months))
- Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)(Follow-Up (about 1 month post-intervention))
- Variability of Stride Time During Walking with Digital Music Device(Baseline 1)
- Variability of Stride Time During Walking with Digital Music Device(Baseline 2 (2-3 weeks after Baseline 1))
- Variability of Stride Time During Walking with Digital Music Device(Immediately after the intervention (about 3 months))
- Variability of Stride Time During Walking with Digital Music Device(Follow-Up (about 1 month post-intervention))
- Speed During Walking with Digital Music Device(Baseline 1)
- Speed During Walking with Digital Music Device(Baseline 2 (2-3 weeks after Baseline 1))
- Speed During Walking with Digital Music Device(Immediately after the intervention (about 3 months))
- Speed During Walking with Digital Music Device(Follow-Up (about 1 month post-intervention))
- Stride Length During Walking with Digital Music Device(Baseline 1)
- Stride Length During Walking with Digital Music Device(Baseline 2 (2-3 weeks after Baseline 1))
- Stride Length During Walking with Digital Music Device(Immediately after the intervention (about 3 months))
- Stride Length During Walking with Digital Music Device(Follow-Up (about 1 month post-intervention))
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline 1)
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline 2 (2-3 weeks after Baseline 1))
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Immediately after the intervention (about 3 months))
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Follow-Up (about 1 month post-intervention))
- Self-Efficacy of Walking - Duration (SEW-D)(Baseline 1)
- Self-Efficacy of Walking - Duration (SEW-D)(Baseline 2 (2-3 weeks after Baseline 1))
- Self-Efficacy of Walking - Duration (SEW-D)(Immediately after the intervention (about 3 months))
- Self-Efficacy of Walking - Duration (SEW-D)(Follow-Up (about 1 month post-intervention))
- Activities-specific Balance Confidence (ABC)(Baseline 1)
- Activities-specific Balance Confidence (ABC)(Baseline 2 (2-3 weeks after Baseline 1))
- Activities-specific Balance Confidence (ABC)(Immediately after the intervention (about 3 months))
- Activities-specific Balance Confidence (ABC)(Follow-Up (about 1 month post-intervention))
- Trail-Making Test (TMT)(Baseline 1)
- Trail-Making Test (TMT)(Baseline 2 (2-3 weeks after Baseline 1))
- Trail-Making Test (TMT)(Immediately after the intervention (about 3 months))
- Trail-Making Test (TMT)(Follow-Up (about 1 month post-intervention))
- Montreal Cognitive Assessment (MoCA)(Baseline 1)
- Montreal Cognitive Assessment (MoCA)(Baseline 2 (2-3 weeks after Baseline 1))
- Montreal Cognitive Assessment (MoCA)(Immediately after the intervention (about 3 months))
- Montreal Cognitive Assessment (MoCA)(Follow-Up (about 1 month post-intervention))
- Variability of Stride Time During MMQ Walking Program with Digital Music Device(During training (about 3 months))
- Speed During MMQ Walking Program with Digital Music Device(During training (about 3 months))
- Stride Length During MMQ Walking Program with Digital Music Device(During training (about 3 months))