A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walking Automaticity in Parkinson Disease

Обзор

The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program called MyMusiQ. The study uses music cues delivered through a digital device in people with Parkinson disease (PD). 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.

Подробное описание

The overall goal of this 3-month single-arm multi-center repeated baselines study (N=162) is to examine the effects of a personalized closed-loop music-based digital gait intervention on improving gait quality, capacity, real-world walking performance, and gait automaticity in Parkinson disease (PD). 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.

The main aims of this mechanistic study seek to examine whether a personalized closed-loop gait intervention improves gait quality, walking capacity, and real-world walking performance beyond baseline variability, and to assess how personalized features influence targeted gait outcomes (Aim 1). Additionally, this study will investigate the effects of the intervention on improving gait automaticity (Aim 2), and identify baseline determinants that predict responsiveness and durability to the intervention on walking capacity (Aim 3). The investigators hypothesize that the intervention will meaningfully improve gait quality (speed, stride length), walking capacity (6-Minute Walk Test), and real-world walking performance (walking intensity and amount) during cued and uncued walking during and after intervention. Furthermore, they hypothesize improvements in gait automaticity (reduced gait variability, dual-tasking costs) following the intervention, and that individuals with worse baseline cognitive-motor capacities may benefit more.

This study will utilize a digital music device (MedRhythms, Inc., Portland, ME). To examine the effects of the intervention, the investigators will use clinical measures of motor and gait function, and quantified movement data on walking using wearable sensors. This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) In-Person Screening and Baseline Assessment #1, (3) Baseline Assessment #2 (2-3 weeks after Baseline Assessment #1) (4) Personalized, Closed-Loop Music-Based Gait Intervention (3 months) (5) Post-Intervention Assessment (immediately after the intervention, about 3 months), and (6) Durability / Follow-Up Assessment (about 1 month post-intervention). Altogether, these procedures may take about 4 months.

Вмешательства

• Устройство Digital Music Device (MedRhythms, Inc., Portland, ME)
  The digital music device is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking perfo

Первичные конечные точки

• Minutes of Moderate Intensity Walking [Срок оценки: Baseline 1]
• Minutes of Moderate Intensity Walking [Срок оценки: Baseline 2 (2-3 weeks after Baseline 1)]
• Minutes of Moderate Intensity Walking [Срок оценки: Immediately after the intervention (about 3 months)]
• Minutes of Moderate Intensity Walking [Срок оценки: Follow-Up (about 1 month post-intervention)]
• Daily Step Counts [Срок оценки: Baseline 1]
• Daily Step Counts [Срок оценки: Baseline 2 (2-3 weeks after Baseline 1)]
• Daily Step Counts [Срок оценки: Immediately after the intervention (about 3 months)]
• Daily Step Counts [Срок оценки: Follow-Up (about 1 month post-intervention)]
• 6-Minute Walk Test [Срок оценки: Baseline 1]
• 6-Minute Walk Test [Срок оценки: Baseline 2 (2-3 weeks after Baseline 1)]

Вторичные конечные точки (12)

• 10-Meter Walk Test (10MWT) - Comfortable Walking Speed [Срок оценки: Baseline 1]
• 10-Meter Walk Test (10MWT) - Comfortable Walking Speed [Срок оценки: Baseline 2 (2-3 weeks after Baseline 1)]
• 10-Meter Walk Test (10MWT) - Comfortable Walking Speed [Срок оценки: Immediately after the intervention (about 3 months)]
• 10-Meter Walk Test (10MWT) - Comfortable Walking Speed [Срок оценки: Follow-Up (about 1 month post-intervention)]
• 10-Meter Walk Test (10MWT) - Fast Walking Speed [Срок оценки: Baseline 1]
• 10-Meter Walk Test (10MWT) - Fast Walking Speed [Срок оценки: Baseline 2 (2-3 weeks after Baseline 1)]
• 10-Meter Walk Test (10MWT) - Fast Walking Speed [Срок оценки: Immediately after the intervention (about 3 months)]
• 10-Meter Walk Test (10MWT) - Fast Walking Speed [Срок оценки: Follow-Up (about 1 month post-intervention)]
• Five Times Sit-to-Stand [Срок оценки: Baseline 1]
• Five Times Sit-to-Stand [Срок оценки: Baseline 2 (2-3 weeks after Baseline 1)]
• Five Times Sit-to-Stand [Срок оценки: Immediately after the intervention (about 3 months)]
• Five Times Sit-to-Stand [Срок оценки: Follow-Up (about 1 month post-intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• < 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Boston University Center for Neurorehabilitation — Boston
• Washington University School of Medicine — St Louis
• University of Utah — Salt Lake City

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. PMID 37840504
• 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. PMID 40438970
• 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. PMID 40301366

Идентификаторы

NCT: NCT07705373 · 8547 · 55213069

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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