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

13 lipca 2026 zaktualizowane przez: 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 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

200

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Erica Clarke, BS
  • Numer telefonu: 617-358-6157
  • E-mail: egclarke@bu.edu

Kopia zapasowa kontaktu do badania

  • Nazwa: Franchino Porciuncula, EdD, PT, DScPT
  • Numer telefonu: 617-353-7571
  • E-mail: fporciun@bu.edu

Lokalizacje studiów

  • Stany Zjednoczone
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02215
        • Boston University Center for Neurorehabilitation
        • Kontakt:
        • Główny śledczy:
          • Terry D. Ellis, PhD, PT
    • Missouri
      • St Louis, Missouri, Stany Zjednoczone, 63110
        • Washington University School of Medicine
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Gammon Earhart, PT, PhD
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84108
        • University of Utah
        • Kontakt:
        • Główny śledczy:
          • Lee Dibble, PT, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: MyMusiQ (MMQ) Walking intervention
12-week self-directed, home/community-based walking intervention that leverages the benefits of rhythmic auditory stimulation via a digital music device (MedRhythms, Inc., Portland, ME) in improving walking outcomes in persons with PD.
Urządzenie: 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 performance metrics.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Minutes of Moderate Intensity Walking
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline 1
Gait speed (m/s) will be measured using research-grade wearable sensors.
Baseline 1
Gait Speed
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline 1
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Baseline 1
Stride Length
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boston University Charles River Campus

Współpracownicy

Washington University School of Medicine
University of Utah
Michael J. Fox Foundation for Parkinson's Research

Śledczy

  • Główny śledczy: Terry D. Ellis, PhD, PT, Boston University Center for Neurorehabilitation

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

28 lutego 2029

Daty rejestracji na studia

Pierwszy przesłany

6 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 lipca 2026

Pierwszy wysłany (Rzeczywisty)

15 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 8547
  • 55213069 (Inny numer grantu/finansowania: Michael J. Fox Foundation)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified data may be shared within reasonable request.

Ramy czasowe udostępniania IPD

Beginning 3 months and ending 3 years after the publication of results

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Choroba Parkinsona (PD)

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Spain

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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