A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walking Automaticity in Parkinson Disease (MyMusiQ)
21 августа 2026 г. обновлено: Boston University Charles River Campus
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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
200
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Erica Clarke, BS
- Номер телефона: 617-358-6157
- Электронная почта: egclarke@bu.edu
Учебное резервное копирование контактов
- Имя: Franchino Porciuncula, EdD PT DScPT
- Номер телефона: 617-353-7571
- Электронная почта: fporciun@bu.edu
Места учебы
-
-
Massachusetts
-
Boston, Massachusetts, Соединенные Штаты, 02215
- Рекрутинг
- Boston University Center for Neurorehabilitation
-
Контакт:
- Erica Clarke, BS
- Номер телефона: 617-358-6157
- Электронная почта: egclarke@bu.edu
-
Главный следователь:
- Terry D. Ellis, PhD, PT
-
-
Missouri
-
St Louis, Missouri, Соединенные Штаты, 63110
- Рекрутинг
- Washington University School of Medicine
-
Контакт:
- Kayla Bell, PT, DPT
- Номер телефона: 314-273-6016
- Электронная почта: kayla.bell@wustl.edu
-
Контакт:
- Kerri Rawson, PhD, MS
- Номер телефона: 813-468-8900
- Электронная почта: rawson@wustl.edu
-
Главный следователь:
- Gammon Earhart, PT, PhD
-
-
Utah
-
Salt Lake City, Utah, Соединенные Штаты, 84108
- Рекрутинг
- University of Utah
-
Контакт:
- Rheanna Anderson, MS
- Номер телефона: 801-587-3615
- Электронная почта: rheanna.anderson@utah.edu
-
Главный следователь:
- Lee Dibble, PT, PhD
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- < 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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
MR-005 (MedRhythms, Inc., Portland, ME) is a personalized, closed-loop, autonomous music-based digital gait intervention designed for self-directed gait training in Parkinson disease (PD).
The system uses two shoe-worn gait sensors that communicate in real time with proprietary software on a touchscreen device, which controls the delivery of individualized, progressive rhythmic auditory stimulation (RAS), provided as music cues through bone conduction headphones.
The software operates autonomously and does not require manual input or adjustment by the patient or clinician during a session.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Minutes of Moderate Intensity Walking
Временное ограничение: 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.
|
Baseline 1
|
|
Minutes of Moderate Intensity Walking
Временное ограничение: 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.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Minutes of Moderate Intensity Walking
Временное ограничение: 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.
|
Immediately after the intervention (about 3 months)
|
|
Minutes of Moderate Intensity Walking
Временное ограничение: 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.
|
Follow-Up (about 1 month post-intervention)
|
|
Daily Step Counts
Временное ограничение: 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.
|
Baseline 1
|
|
Daily Step Counts
Временное ограничение: 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.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Daily Step Counts
Временное ограничение: 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.
|
Immediately after the intervention (about 3 months)
|
|
Daily Step Counts
Временное ограничение: 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.
|
Follow-Up (about 1 month post-intervention)
|
|
6-Minute Walk Test
Временное ограничение: 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.
|
Baseline 1
|
|
6-Minute Walk Test
Временное ограничение: 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.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
6-Minute Walk Test
Временное ограничение: 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.
|
Immediately after the intervention (about 3 months)
|
|
6-Minute Walk Test
Временное ограничение: 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.
|
Follow-Up (about 1 month post-intervention)
|
|
Gait Speed
Временное ограничение: Baseline 1
|
Gait speed (m/s) will be measured using research-grade wearable sensors.
|
Baseline 1
|
|
Gait Speed
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
Gait speed (m/s) will be measured using research-grade wearable sensors.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Gait Speed
Временное ограничение: Immediately after the intervention (about 3 months)
|
Gait speed (m/s) will be measured using research-grade wearable sensors.
|
Immediately after the intervention (about 3 months)
|
|
Gait Speed
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
Gait speed (m/s) will be measured using research-grade wearable sensors.
|
Follow-Up (about 1 month post-intervention)
|
|
Stride Length
Временное ограничение: Baseline 1
|
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
|
Baseline 1
|
|
Stride Length
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Stride Length
Временное ограничение: Immediately after the intervention (about 3 months)
|
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
|
Immediately after the intervention (about 3 months)
|
|
Stride Length
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
|
Follow-Up (about 1 month post-intervention)
|
|
Variability of Stride Time
Временное ограничение: 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.
|
Baseline 1
|
|
Variability of Stride Time
Временное ограничение: 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.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Variability of Stride Time
Временное ограничение: 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.
|
Immediately after the intervention (about 3 months)
|
|
Variability of Stride Time
Временное ограничение: 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.
|
Follow-Up (about 1 month post-intervention)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Временное ограничение: Baseline 1
|
This is a test of short-distance walking function.
The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.
|
Baseline 1
|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
This is a test of short-distance walking function.
The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Временное ограничение: Immediately after the intervention (about 3 months)
|
This is a test of short-distance walking function.
The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.
|
Immediately after the intervention (about 3 months)
|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
This is a test of short-distance walking function.
The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.
|
Follow-Up (about 1 month post-intervention)
|
|
10-Meter Walk Test (10MWT) - Fast Walking Speed
Временное ограничение: Baseline 1
|
This is a test of short-distance walking function.
The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.
|
Baseline 1
|
|
10-Meter Walk Test (10MWT) - Fast Walking Speed
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
This is a test of short-distance walking function.
The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
10-Meter Walk Test (10MWT) - Fast Walking Speed
Временное ограничение: Immediately after the intervention (about 3 months)
|
This is a test of short-distance walking function.
The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.
|
Immediately after the intervention (about 3 months)
|
|
10-Meter Walk Test (10MWT) - Fast Walking Speed
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
This is a test of short-distance walking function.
The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.
|
Follow-Up (about 1 month post-intervention)
|
|
Five Times Sit-to-Stand
Временное ограничение: Baseline 1
|
This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.
|
Baseline 1
|
|
Five Times Sit-to-Stand
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Five Times Sit-to-Stand
Временное ограничение: Immediately after the intervention (about 3 months)
|
This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.
|
Immediately after the intervention (about 3 months)
|
|
Five Times Sit-to-Stand
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.
|
Follow-Up (about 1 month post-intervention)
|
|
Generic Walking Scale (Walk-12G)
Временное ограничение: Baseline 1
|
This test is a self-report questionnaire that measures everyday walking difficulties.
Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.
|
Baseline 1
|
|
Generic Walking Scale (Walk-12G)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
This test is a self-report questionnaire that measures everyday walking difficulties.
Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Generic Walking Scale (Walk-12G)
Временное ограничение: Immediately after the intervention (about 3 months)
|
This test is a self-report questionnaire that measures everyday walking difficulties.
Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.
|
Immediately after the intervention (about 3 months)
|
|
Generic Walking Scale (Walk-12G)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
This test is a self-report questionnaire that measures everyday walking difficulties.
Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.
|
Follow-Up (about 1 month post-intervention)
|
|
Global Rating of Change (GROC) Scale
Временное ограничение: Immediately after the intervention (about 3 months)
|
This self-reported rating scale measures overall perceived improvement in areas related to amount of walking, intensity of walking, and walking capacity.
Scores range from -7 to +7, with higher scores indicating greater improvement.
|
Immediately after the intervention (about 3 months)
|
|
Mini Balance Evaluation Systems Test (Mini-BESTest)
Временное ограничение: Baseline 1
|
This test is a clinical balance assessment tool designed to examine various elements of balance control.
Scores range from 0 to 28, with higher scores indicating better balance.
|
Baseline 1
|
|
Mini Balance Evaluation Systems Test (Mini-BESTest)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
This test is a clinical balance assessment tool designed to examine various elements of balance control.
Scores range from 0 to 28, with higher scores indicating better balance.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Mini Balance Evaluation Systems Test (Mini-BESTest)
Временное ограничение: Immediately after the intervention (about 3 months)
|
This test is a clinical balance assessment tool designed to examine various elements of balance control.
Scores range from 0 to 28, with higher scores indicating better balance.
|
Immediately after the intervention (about 3 months)
|
|
Mini Balance Evaluation Systems Test (Mini-BESTest)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
This test is a clinical balance assessment tool designed to examine various elements of balance control.
Scores range from 0 to 28, with higher scores indicating better balance.
|
Follow-Up (about 1 month post-intervention)
|
|
Prefrontal Cortex Activity
Временное ограничение: Baseline 1
|
Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking.
This will be collected only for the cohort at Boston University.
|
Baseline 1
|
|
Prefrontal Cortex Activity
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking.
This will be collected only for the cohort at Boston University.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Prefrontal Cortex Activity
Временное ограничение: Immediately after the intervention (about 3 months)
|
Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking.
This will be collected only for the cohort at Boston University.
|
Immediately after the intervention (about 3 months)
|
|
Dual-Task Cost on Gait Speed
Временное ограничение: Baseline 1
|
Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.
|
Baseline 1
|
|
Dual-Task Cost on Gait Speed
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Dual-Task Cost on Gait Speed
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.
|
Follow-Up (about 1 month post-intervention)
|
|
Dual-Task Cost on Gait Speed
Временное ограничение: Immediately after the intervention (about 3 months)
|
Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.
|
Immediately after the intervention (about 3 months)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)
Временное ограничение: Baseline 1
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part I is an examination of non-motor experiences of daily living.
Part IA is conducted by the rater, and Part IB is completed independently of the rater.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Baseline 1
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part I is an examination of non-motor experiences of daily living.
Part IA is conducted by the rater, and Part IB is completed independently of the rater.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)
Временное ограничение: Immediately after the intervention (about 3 months)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part I is an examination of non-motor experiences of daily living.
Part IA is conducted by the rater, and Part IB is completed independently of the rater.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Immediately after the intervention (about 3 months)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part I is an examination of non-motor experiences of daily living.
Part IA is conducted by the rater, and Part IB is completed independently of the rater.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Follow-Up (about 1 month post-intervention)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)
Временное ограничение: Baseline 1
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part II is a self-administered questionnaire to examine motor experiences of daily living.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Baseline 1
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part II is a self-administered questionnaire to examine motor experiences of daily living.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part II is a self-administered questionnaire to examine motor experiences of daily living.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Follow-Up (about 1 month post-intervention)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)
Временное ограничение: Immediately after the intervention (about 3 months)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part II is a self-administered questionnaire to examine motor experiences of daily living.
Scores range from 0 to 52, with higher scores indicating greater impairment.
|
Immediately after the intervention (about 3 months)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)
Временное ограничение: Baseline 1
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part III is a motor examination conducted by the rater.
Scores range from 0 to 132, with higher scores indicating greater impairment.
|
Baseline 1
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part III is a motor examination conducted by the rater.
Scores range from 0 to 132, with higher scores indicating greater impairment.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)
Временное ограничение: Immediately after the intervention (about 3 months)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part III is a motor examination conducted by the rater.
Scores range from 0 to 132, with higher scores indicating greater impairment.
|
Immediately after the intervention (about 3 months)
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease.
Part III is a motor examination conducted by the rater.
Scores range from 0 to 132, with higher scores indicating greater impairment.
|
Follow-Up (about 1 month post-intervention)
|
|
Variability of Stride Time During Walking with Digital Music Device
Временное ограничение: Baseline 1
|
Stride time variability will be measured during walking with digital music device during in-lab assessments.
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.
|
Baseline 1
|
|
Variability of Stride Time During Walking with Digital Music Device
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
Stride time variability will be measured during walking with digital music device during in-lab assessments.
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.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Variability of Stride Time During Walking with Digital Music Device
Временное ограничение: Immediately after the intervention (about 3 months)
|
Stride time variability will be measured during walking with digital music device during in-lab assessments.
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.
|
Immediately after the intervention (about 3 months)
|
|
Variability of Stride Time During Walking with Digital Music Device
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
Stride time variability will be measured during walking with digital music device during in-lab assessments.
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.
|
Follow-Up (about 1 month post-intervention)
|
|
Speed During Walking with Digital Music Device
Временное ограничение: Baseline 1
|
Speed (m/s) will be measured during walking with digital music device during in-lab assessments.
|
Baseline 1
|
|
Speed During Walking with Digital Music Device
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
Speed (m/s) will be measured during walking with digital music device during in-lab assessments.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Speed During Walking with Digital Music Device
Временное ограничение: Immediately after the intervention (about 3 months)
|
Speed (m/s) will be measured during walking with digital music device during in-lab assessments.
|
Immediately after the intervention (about 3 months)
|
|
Speed During Walking with Digital Music Device
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
Speed (m/s) will be measured during walking with digital music device during in-lab assessments.
|
Follow-Up (about 1 month post-intervention)
|
|
Stride Length During Walking with Digital Music Device
Временное ограничение: Baseline 1
|
Stride length (m) will be measured during walking with digital music device during in-lab assessments.
|
Baseline 1
|
|
Stride Length During Walking with Digital Music Device
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
Stride length (m) will be measured during walking with digital music device during in-lab assessments.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Stride Length During Walking with Digital Music Device
Временное ограничение: Immediately after the intervention (about 3 months)
|
Stride length (m) will be measured during walking with digital music device during in-lab assessments.
|
Immediately after the intervention (about 3 months)
|
|
Stride Length During Walking with Digital Music Device
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
Stride length (m) will be measured during walking with digital music device during in-lab assessments.
|
Follow-Up (about 1 month post-intervention)
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39)
Временное ограничение: Baseline 1
|
The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions.
Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).
|
Baseline 1
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions.
Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39)
Временное ограничение: Immediately after the intervention (about 3 months)
|
The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions.
Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).
|
Immediately after the intervention (about 3 months)
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions.
Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).
|
Follow-Up (about 1 month post-intervention)
|
|
Self-Efficacy of Walking - Duration (SEW-D)
Временное ограничение: Baseline 1
|
The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.
|
Baseline 1
|
|
Self-Efficacy of Walking - Duration (SEW-D)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Self-Efficacy of Walking - Duration (SEW-D)
Временное ограничение: Immediately after the intervention (about 3 months)
|
The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.
|
Immediately after the intervention (about 3 months)
|
|
Self-Efficacy of Walking - Duration (SEW-D)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.
|
Follow-Up (about 1 month post-intervention)
|
|
Activities-specific Balance Confidence (ABC)
Временное ограничение: Baseline 1
|
This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities.
The scores range from 0 to 100, with higher scores indicating greater confidence.
|
Baseline 1
|
|
Activities-specific Balance Confidence (ABC)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities.
The scores range from 0 to 100, with higher scores indicating greater confidence.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Activities-specific Balance Confidence (ABC)
Временное ограничение: Immediately after the intervention (about 3 months)
|
This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities.
The scores range from 0 to 100, with higher scores indicating greater confidence.
|
Immediately after the intervention (about 3 months)
|
|
Activities-specific Balance Confidence (ABC)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities.
The scores range from 0 to 100, with higher scores indicating greater confidence.
|
Follow-Up (about 1 month post-intervention)
|
|
Trail-Making Test (TMT)
Временное ограничение: Baseline 1
|
This test measures the time it takes (seconds) to complete two visual-motor tasks.
Higher scores indicate slower processing speed and greater cognitive impairment.
|
Baseline 1
|
|
Trail-Making Test (TMT)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
This test measures the time it takes (seconds) to complete two visual-motor tasks.
Higher scores indicate slower processing speed and greater cognitive impairment.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Trail-Making Test (TMT)
Временное ограничение: Immediately after the intervention (about 3 months)
|
This test measures the time it takes (seconds) to complete two visual-motor tasks.
Higher scores indicate slower processing speed and greater cognitive impairment.
|
Immediately after the intervention (about 3 months)
|
|
Trail-Making Test (TMT)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
This test measures the time it takes (seconds) to complete two visual-motor tasks.
Higher scores indicate slower processing speed and greater cognitive impairment.
|
Follow-Up (about 1 month post-intervention)
|
|
Montreal Cognitive Assessment (MoCA)
Временное ограничение: Baseline 1
|
The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment.
The score ranges from 0-30, with higher scores indicating less cognitive impairment.
|
Baseline 1
|
|
Montreal Cognitive Assessment (MoCA)
Временное ограничение: Baseline 2 (2-3 weeks after Baseline 1)
|
The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment.
The score ranges from 0-30, with higher scores indicating less cognitive impairment.
|
Baseline 2 (2-3 weeks after Baseline 1)
|
|
Montreal Cognitive Assessment (MoCA)
Временное ограничение: Immediately after the intervention (about 3 months)
|
The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment.
The score ranges from 0-30, with higher scores indicating less cognitive impairment.
|
Immediately after the intervention (about 3 months)
|
|
Montreal Cognitive Assessment (MoCA)
Временное ограничение: Follow-Up (about 1 month post-intervention)
|
The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment.
The score ranges from 0-30, with higher scores indicating less cognitive impairment.
|
Follow-Up (about 1 month post-intervention)
|
|
Variability of Stride Time During MMQ Walking Program with Digital Music Device
Временное ограничение: During training (about 3 months)
|
Stride time variability will be measured during the MMQ walking program with the digital music device.
Stride-to-stride variability of stride time of the gait cycle will be measured using integrated sensors from the music device.
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.
|
During training (about 3 months)
|
|
Speed During MMQ Walking Program with Digital Music Device
Временное ограничение: During training (about 3 months)
|
Speed (m/s) will be measured during the MMQ walking program with the digital music device.
Speed will be measured using integrated sensors from the music device.
|
During training (about 3 months)
|
|
Stride Length During MMQ Walking Program with Digital Music Device
Временное ограничение: During training (about 3 months)
|
Stride length (m) will be measured during the MMQ walking program with the digital music device.
Stride length will be measured using integrated sensors from the music device.
|
During training (about 3 months)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Terry D. Ellis, PhD PT, Boston University Center for Neurorehabilitation
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Zajac JA, Porciuncula F, Cavanaugh JT, McGregor C, Harris BA, Smayda KE, Awad LN, Pantelyat A, Ellis TD. Feasibility and Proof-of-Concept of Delivering an Autonomous Music-Based Digital Walking Intervention to Persons with Parkinson's Disease in a Naturalistic Setting. J Parkinsons Dis. 2023;13(7):1253-1265. doi: 10.3233/JPD-230169.
- Cavanaugh JT, Porciuncula F, Zajac JA, Baker T, Wendel N, Awad LN, Ellis TD. Gait Responses in People with Parkinson Disease During Autonomous Closed-loop Rhythmic Auditory Stimulation: An Exploratory Analysis. Neurorehabil Neural Repair. 2025 Aug;39(8):666-676. doi: 10.1177/15459683251340910. Epub 2025 May 29.
- Porciuncula F, Cavanaugh JT, Zajac J, Wendel N, Baker T, Arumukhom Revi D, Eklund N, Holmes MB, Awad LN, Ellis TD. Amplifying walking activity in Parkinson's disease through autonomous music-based rhythmic auditory stimulation: randomized controlled trial. NPJ Parkinsons Dis. 2025 Apr 29;11(1):100. doi: 10.1038/s41531-025-00952-x.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
20 августа 2026 г.
Первичное завершение (Оцененный)
31 декабря 2028 г.
Завершение исследования (Оцененный)
28 февраля 2029 г.
Даты регистрации исследования
Первый отправленный
6 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
13 июля 2026 г.
Первый опубликованный (Действительный)
15 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
24 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 8547
- 55213069 (Другой номер гранта/финансирования: Michael J. Fox Foundation)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
De-identified data may be shared within reasonable request.
Сроки обмена IPD
Beginning 3 months and ending 3 years after the publication of results
Критерии совместного доступа к IPD
Data relevant to eventual publication may be made available within reasonable request.
Other datasets generated from the study may be accessed through requests in compliance with the study funder's protocol.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .