A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walking Automaticity in Parkinson Disease (MyMusiQ)
2026년 8월 21일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
200
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Erica Clarke, BS
- 전화번호: 617-358-6157
- 이메일: egclarke@bu.edu
연구 연락처 백업
- 이름: Franchino Porciuncula, EdD PT DScPT
- 전화번호: 617-353-7571
- 이메일: fporciun@bu.edu
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- 모병
- Boston University Center for Neurorehabilitation
-
연락하다:
- Erica Clarke, BS
- 전화번호: 617-358-6157
- 이메일: egclarke@bu.edu
-
수석 연구원:
- Terry D. Ellis, PhD, PT
-
-
Missouri
-
St Louis, Missouri, 미국, 63110
- 모병
- Washington University School of Medicine
-
연락하다:
- Kayla Bell, PT, DPT
- 전화번호: 314-273-6016
- 이메일: kayla.bell@wustl.edu
-
연락하다:
- Kerri Rawson, PhD, MS
- 전화번호: 813-468-8900
- 이메일: rawson@wustl.edu
-
수석 연구원:
- Gammon Earhart, PT, PhD
-
-
Utah
-
Salt Lake City, Utah, 미국, 84108
- 모병
- University of Utah
-
연락하다:
- Rheanna Anderson, MS
- 전화번호: 801-587-3615
- 이메일: rheanna.anderson@utah.edu
-
수석 연구원:
- Lee Dibble, PT, PhD
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Minutes of Moderate Intensity Walking
기간: 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.
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Baseline 1
|
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Minutes of Moderate Intensity Walking
기간: 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
기간: 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
기간: 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
기간: 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
|
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Daily Step Counts
기간: 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)
|
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Daily Step Counts
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline 1
|
Gait speed (m/s) will be measured using research-grade wearable sensors.
|
Baseline 1
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Gait Speed
기간: 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
기간: 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
기간: 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)
|
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Stride Length
기간: Baseline 1
|
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
|
Baseline 1
|
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Stride Length
기간: Baseline 2 (2-3 weeks after Baseline 1)
|
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
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Baseline 2 (2-3 weeks after Baseline 1)
|
|
Stride Length
기간: 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
기간: 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)
|
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Variability of Stride Time
기간: 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
|
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Variability of Stride Time
기간: 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.
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Baseline 2 (2-3 weeks after Baseline 1)
|
|
Variability of Stride Time
기간: 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
기간: 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)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
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Five Times Sit-to-Stand
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
|
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Mini Balance Evaluation Systems Test (Mini-BESTest)
기간: 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)
기간: 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)
기간: 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
기간: 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
|
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Prefrontal Cortex Activity
기간: 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
기간: 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
기간: 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
|
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Dual-Task Cost on Gait Speed
기간: 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
기간: 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
기간: 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)
기간: 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
|
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Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Terry D. Ellis, PhD PT, Boston University Center for Neurorehabilitation
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 8월 20일
기본 완료 (추정된)
기본 완료
2028년 12월 31일
연구 완료 (추정된)
연구 완료
2029년 2월 28일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 21일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 8547
- 55213069 (기타 보조금/기금 번호: Michael J. Fox Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified data may be shared within reasonable request.
IPD 공유 기간
Beginning 3 months and ending 3 years after the publication of results
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .