Parkinson's Disease (PD)
Conditions
Keywords
Music-based intervention, Gait quality, Walking capacity, Gait automaticity, Parkinson's Disease (PD)
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMR-005 (MedRhythms, Inc., Portland, ME)
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.
Sponsors
Boston University Charles River Campus
Michael J. Fox Foundation for Parkinson's Research
University of Utah
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variability of Stride Time | 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. |
| Minutes of Moderate Intensity Walking | 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. |
| Daily Step Counts | 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. |
| 6-Minute Walk Test | 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. |
| Gait Speed | Baseline 1 | Gait speed (m/s) will be measured using research-grade wearable sensors. |
| Stride Length | Baseline 1 | Quantified metrics of stride length (m) will be collected using research-grade wearable sensors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini Balance Evaluation Systems Test (Mini-BESTest) | 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. |
| Prefrontal Cortex Activity | 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. |
| Dual-Task Cost on Gait Speed | 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. |
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I) | 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. |
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II) | 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. |
| Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III) | 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. |
| Trail-Making Test (TMT) | 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. |
| Montreal Cognitive Assessment (MoCA) | 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. |
| Variability of Stride Time During MMQ Walking Program with Digital Music Device | 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. |
| Speed During MMQ Walking Program with Digital Music Device | 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. |
| Stride Length During MMQ Walking Program with Digital Music Device | 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. |
| Variability of Stride Time During Walking with Digital Music Device | 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. |
| Speed During Walking with Digital Music Device | Baseline 1 | Speed (m/s) will be measured during walking with digital music device during in-lab assessments. |
| Stride Length During Walking with Digital Music Device | Baseline 1 | Stride length (m) will be measured during walking with digital music device during in-lab assessments. |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | 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). |
| Self-Efficacy of Walking - Duration (SEW-D) | 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. |
| Activities-specific Balance Confidence (ABC) | 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. |
| 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | 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. |
| 10-Meter Walk Test (10MWT) - Fast Walking Speed | 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. |
| Five Times Sit-to-Stand | 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. |
| Generic Walking Scale (Walk-12G) | 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. |
| Global Rating of Change (GROC) Scale | 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. |
Countries
United States
Contacts
CONTACTErica Clarke, BS
CONTACTFranchino Porciuncula, EdD PT DScPT
PRINCIPAL_INVESTIGATORTerry D. Ellis, PhD PT
Boston University Center for Neurorehabilitation
Outcome results
None listed