Parkinson DiseaseAmped-PDNCT05421624
Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease
A study testing Digital music therapeutic in people with Parkinson Disease, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Regular, habitual exercise is a critical component of the long-term management of Parkinson disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Digital music therapeutic
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic, typical Parkinson disease (based on the UK PD Society Brain Bank Criteria7) by a physician
- Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist
- 40 - 85 years of age
- Community-dwelling
- Able to walk independently without physical assistance or an assistive device for at least 10 minutes.
- Have stable PD medications for at least two weeks prior to enrollment.
- 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.
Who cannot join
- < 40 years of age
- Diagnosis of atypical Parkinsonism
- Modified Hoehn and Yahr stages 4-5
- Moderately or significantly disturbing freezing episodes during daily walking based on the New Freezing of Gait Questionnaire
- History of >1 fall over the past 3 months
- Cognitive impairment (i.e., Mini-Mental State Exam Score (MMSE) < 24)
Show all 14Show fewer
- Unable to walk independently (i.e. without physical assistance or assistive device) at a comfortable speed of 0.4m/s or greater (i.e., 10-meter Walk Test (10mWT))
- Unable to independently use the music-based digital therapeutic during training
- Significant hearing impairment
- Currently participating in physical therapy
- Currently performing regular walking exercise > 3x/week for 30 minutes per session.
- Cardiac conditions that may limit safe participation in exercise
- Orthopedic conditions that may limit safe participation in exercise
- Any other medical conditions that would preclude successful participation as determined by a physical therapist
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Neurorehabilitation at Boston University
Boston, Massachusetts, 02215
About this study
Official title: Amped-PD: Amplifying Physical Activity Through a Novel Digital Music Therapeutic in Parkinson Disease
Regular, habitual exercise is a critical component of the long-term management of Parkinson disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting moderate intensity walking activity -- an important health-objective in the management of PD. However, the therapeutic potential of RAS in self-directed walking programs has not been examined. In this pilot, we will utilize a breakthrough digital therapeutic that delivers music-adaptive RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. Habits are automatically recurring psychological dispositions that emerge from repeated behaviors. The investigators posit that music cues provide recurring contextual cues that automatically evoke habitual response of exercise, thus has the potential to prompt regular physical activity. This study will enroll 61individuals with mild-to-moderate PD (Run-in: 17; Main Trial: 44). The experimental intervention, "Amped-PD", is a 6-week, user-managed community-based walking program that utilizes music-adaptive RAS that progressively increases walking intensities. This study will examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking, and in improving motor deficits related to quality of walking in individuals with mild-to-moderate PD. This study will also examine whether the resultant habits formed from each intervention matter in relation to training-related changes in physical activity.
Read the detailed description
Parkinson disease (PD) is the fastest growing source of disability among neurological disorders. Diminished physical activity is highly prevalent in PD and often lead to the onset of disability. Regular, habitual exercise is a critical component of the long-term PD management. However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs the coupling of auditory cues with movement. When used during walking, RAS has been shown to benefit walking rhythmicity, quality, and speed. Therefore this rehabilitation technique can be advantageous in promoting moderate intensity walking activity. While clinical studies support RAS-based intervention, its translation to real-world, community-based environments and for long-term exercise for the promotion of physical activity is limited. The difference that determines viability of RAS for out-of-lab applications lie in the distinction between external entrainment (open-loop) versus autonomous entrainment (closed-loop). Open-loop RAS requires high levels of vigilance and is prone to error accumulation, which is problematic with gait dysfunction in PD. On the other hand, closed-loop RAS allows for natural and stable entrainment. A closed-loop approach in this case is a necessity of the task and a technological challenge to translate RAS to community-based settings. In this pilot, the investigators will utilize a breakthrough digital therapeutic that employs closed-loop RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. The investigators posit that music that is linked to enjoyment serves as context cues that define the pre-condition to engaging in habitual walking exercise and increased physical activity. With repetition, these recurring contextual triggers (i.e. music) automatically evoke a habitual response of exercise, and thus has the potential to amplify physical activity.
The main aims of the study seek to examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking (Aim 1), and in improving motor deficits related to quality of walking (Aim 2) in individuals with mild-to-moderate PD. Additionally, this study will examine whether habit formation mediates the relationship between the intervention (Amped-PD or Active-Control) and physical activity (Aim 3). The investigators hypothesize that Amped-PD will have greater improvements in amounts of moderate intensity walking and stride-to-stride variability based on stride length and swing time. Further, habit formation will be one mechanism that will explain the link between the intervention and physical activity. Secondary research aims will examine whether Amped-PD is more effective than Active-Control in improving motor and non-motor features based on short- and long-distance walking function, spatiotemporal measures of walking, step activity based on daily step counts, disease severity scores, quality of life, self-efficacy on walking, and depression.
This study will utilize the breakthrough digital music therapeutic developed and manufactured by MedRhythms (Portland, ME). To examine the effects of the intervention, the investigators will use clinical measures of motor and gait function, participant self-reports on habit formation, and quantified movement data on walking and physical activity using wearable sensors. This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) Clinical Screening and Baseline Assessment, (3) Community-based, self-directed walking program (6 weeks), (3) Post-training Assessment; (4) Follow-up training (2 weeks), and (5) Final Follow-Up Assessment. Altogether, these procedures may take up to 10 weeks.
- Conditions
- Parkinson Disease
- Being tested
- Digital music therapeutic, Active-Control
- Keywords
- Parkinson disease, rhythmic auditory stimulation, digital therapeutics, behavior change, habits, physical activity
- Medical subject headings
- Parkinson Disease, Habits, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital music therapeuticDevice
Also called MedRhythms device
The digital music therapeutic 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.
Active-ControlBehavioural
The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
| Study group | Role | What they receive |
|---|---|---|
| Amped-PD | Experimental | 6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation. Receives: Device: Digital music therapeutic |
| Active-Control | Active comparator | 6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation. Receives: Behavioral: Active-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: Baseline
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: During training up to 4 days from start of training
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: Immediately after the intervention (up to 6 weeks)
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: Follow-up (up to 2 weeks post-intervention)
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: Baseline
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: During training up to 4 days from start of training
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: Immediately after the intervention (up to 6 weeks)
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Gait Quality Based on Variability of Stride Time
Stride-to-stride variability of stride time of the gait cycle will be measured using 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 percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Measured: Baseline
Gait Quality Based on Variability of Stride Time
Stride-to-stride variability of stride time of the gait cycle will be measured using 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 percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Measured: Immediately after the intervention (up to 6 weeks)
Gait Quality Based on Variability of Stride Time
Stride-to-stride variability of stride time of the gait cycle will be measured using 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 percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Self-Report Habit Index (SRHI)
The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
Measured: Baseline
Self-Report Habit Index (SRHI)
The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Secondary outcomes (30)
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
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. Two trials will be administered, and the average of two trials will be reported.
Measured: Baseline
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
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. Two trials will be administered, and the average of two trials will be reported.
Measured: Immediately after the intervention (up to 6 weeks)
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
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. Two trials will be administered, and the average of two trials will be reported.
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
10-Meter Walk Test (10MWT) - Maximum Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Measured: Baseline
10-Meter Walk Test (10MWT) - Maximum Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Measured: Immediately after the intervention (up to 6 weeks)
10-Meter Walk Test (10MWT) - Maximum Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test.
Measured: Baseline
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test.
Measured: Immediately after the intervention (up to 6 weeks)
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test.
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Gait Velocity During In-clinic Walking
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Measured: Baseline
Gait Velocity During In-clinic Walking
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Measured: Immediately after the intervention (up to 6 weeks)
Gait Velocity During In-clinic Walking
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Stride Length During In-clinic Walking
Quantified metrics of stride length (m) will be collected using wearable sensors.
Measured: Baseline
Stride Length During In-clinic Walking
Quantified metrics of stride length (m) will be collected using wearable sensors.
Measured: Immediately after the intervention (up to 6 weeks)
Stride Length During In-clinic Walking
Quantified metrics of stride length (m) will be collected using wearable sensors.
Measured: Follow-up (up to 2 weeks post-intervention)
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Measured: Baseline
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Measured: Immediately after the intervention (up to 6 weeks)
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Self-Efficacy of Walking - Duration (SEW-D)
The SEW-D is a 10-item 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).
Measured: Baseline
Self-Efficacy of Walking - Duration (SEW-D)
The SEW-D is a 10-item 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).
Measured: Immediately after the intervention (up to 6 weeks)
Self-Efficacy of Walking - Duration (SEW-D)
The SEW-D is a 10-item 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).
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Geriatric Depression Scale (GDS)
The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Measured: Baseline
Geriatric Depression Scale (GDS)
The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Measured: Immediately after the intervention (up to 6 weeks)
Geriatric Depression Scale (GDS)
The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Parkinson's Disease Questionnaire - 39 (PDQ-39)
The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Measured: Baseline
Parkinson's Disease Questionnaire - 39 (PDQ-39)
The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Measured: Immediately after the intervention (up to 6 weeks)
Parkinson's Disease Questionnaire - 39 (PDQ-39)
The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Mini Balance Evaluation Systems Test (Mini BESTest)
This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Measured: Baseline
Mini Balance Evaluation Systems Test (Mini BESTest)
This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Measured: Immediately after the intervention (up to 6 weeks)
Mini Balance Evaluation Systems Test (Mini BESTest)
This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Measured: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either intervention of (1) Amped-PD, or (2) Active-Control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of New England, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Franchino Porciuncula, PT, EdD, Principal investigator, Boston UniversityTerry D. Ellis, PT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421624
- Sponsor's protocol ID
- 6518
- Other IDs
- P30AG048785
- Acronym
- Amped-PD
- Status last verified
- May 2025
- First submitted
- 9 Jun 2022
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Toward Understanding Ambulatory Activity Decline in Parkinson Disease. Phys Ther. 2015 Aug;95(8):1142-50. doi: 10.2522/ptj.20140498. Epub 2015 Apr 9.
PubMed 25858971Ellis TD, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Thackeray A, Thiese MS, Dibble LE. Identifying clinical measures that most accurately reflect the progression of disability in Parkinson disease. Parkinsonism Relat Disord. 2016 Apr;25:65-71. doi: 10.1016/j.parkreldis.2016.02.006. Epub 2016 Feb 2.
PubMed 26876037Nombela C, Hughes LE, Owen AM, Grahn JA. Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3.
PubMed 24012774Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Mov Disord. 1996 Mar;11(2):193-200. doi: 10.1002/mds.870110213.
PubMed 8684391Hutchinson K, Sloutsky R, Collimore A, Adams B, Harris B, Ellis TD, Awad LN. A Music-Based Digital Therapeutic: Proof-of-Concept Automation of a Progressive and Individualized Rhythm-Based Walking Training Program After Stroke. Neurorehabil Neural Repair. 2020 Nov;34(11):986-996. doi: 10.1177/1545968320961114. Epub 2020 Oct 10.
PubMed 33040685Gardner B. A review and analysis of the use of 'habit' in understanding, predicting and influencing health-related behaviour. Health Psychol Rev. 2015;9(3):277-95. doi: 10.1080/17437199.2013.876238. Epub 2014 Jan 21.
PubMed 25207647Galla BM, Duckworth AL. More than resisting temptation: Beneficial habits mediate the relationship between self-control and positive life outcomes. J Pers Soc Psychol. 2015 Sep;109(3):508-25. doi: 10.1037/pspp0000026. Epub 2015 Feb 2.
PubMed 25643222Wittwer JE, Winbolt M, Morris ME. Home-Based Gait Training Using Rhythmic Auditory Cues in Alzheimer's Disease: Feasibility and Outcomes. Front Med (Lausanne). 2020 Jan 31;6:335. doi: 10.3389/fmed.2019.00335. eCollection 2019.
PubMed 32083083Jeng B, Cederberg KL, Lai B, Sasaki JE, Bamman MM, Motl RW. Step-rate threshold for physical activity intensity in Parkinson's disease. Acta Neurol Scand. 2020 Aug;142(2):145-150. doi: 10.1111/ane.13250. Epub 2020 Apr 22.
PubMed 32255504Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.
PubMed 21798044Cavanaugh 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.
PubMed 40438970Porciuncula 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.
PubMed 40301366
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amped-PD: Amplifying Physical Activity Through a Novel Digital Music Therapeutic in Parkinson Disease
- ClinicalTrials.gov ID
- NCT05421624
- Acronym / sponsor ID
- Amped-PD / 6518
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, rhythmic auditory stimulation, digital therapeutics, behavior change, habits, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of New England, National Institute on Aging (NIA)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regular, habitual exercise is a critical component of the long-term management of Parkinson disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting moderate intensity walking activity -- an important health-objective in the management of PD. However, the therapeutic potential of RAS in self-directed walking programs has not been examined. In this pilot, we will utilize a breakthrough digital therapeutic that delivers music-adaptive RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. Habits are automatically recurring psychological dispositions that emerge from repeated behaviors. The investigators posit that music cues provide recurring contextual cues that automatically evoke habitual response of exercise, thus has the potential to prompt regular physical activity. This study will enroll 61individuals with mild-to-moderate PD (Run-in: 17; Main Trial: 44). The experimental intervention, "Amped-PD", is a 6-week, user-managed community-based walking program that utilizes music-adaptive RAS that progressively increases walking intensities. This study will examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking, and in improving motor deficits related to quality of walking in individuals with mild-to-moderate PD. This study will also examine whether the resultant habits formed from each intervention matter in relation to training-related changes in physical activity.
Detailed description
Parkinson disease (PD) is the fastest growing source of disability among neurological disorders. Diminished physical activity is highly prevalent in PD and often lead to the onset of disability. Regular, habitual exercise is a critical component of the long-term PD management. However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs the coupling of auditory cues with movement. When used during walking, RAS has been shown to benefit walking rhythmicity, quality, and speed. Therefore this rehabilitation technique can be advantageous in promoting moderate intensity walking activity. While clinical studies support RAS-based intervention, its translation to real-world, community-based environments and for long-term exercise for the promotion of physical activity is limited. The difference that determines viability of RAS for out-of-lab applications lie in the distinction between external entrainment (open-loop) versus autonomous entrainment (closed-loop). Open-loop RAS requires high levels of vigilance and is prone to error accumulation, which is problematic with gait dysfunction in PD. On the other hand, closed-loop RAS allows for natural and stable entrainment. A closed-loop approach in this case is a necessity of the task and a technological challenge to translate RAS to community-based settings. In this pilot, the investigators will utilize a breakthrough digital therapeutic that employs closed-loop RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. The investigators posit that music that is linked to enjoyment serves as context cues that define the pre-condition to engaging in habitual walking exercise and increased physical activity. With repetition, these recurring contextual triggers (i.e. music) automatically evoke a habitual response of exercise, and thus has the potential to amplify physical activity.
The main aims of the study seek to examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking (Aim 1), and in improving motor deficits related to quality of walking (Aim 2) in individuals with mild-to-moderate PD. Additionally, this study will examine whether habit formation mediates the relationship between the intervention (Amped-PD or Active-Control) and physical activity (Aim 3). The investigators hypothesize that Amped-PD will have greater improvements in amounts of moderate intensity walking and stride-to-stride variability based on stride length and swing time. Further, habit formation will be one mechanism that will explain the link between the intervention and physical activity. Secondary research aims will examine whether Amped-PD is more effective than Active-Control in improving motor and non-motor features based on short- and long-distance walking function, spatiotemporal measures of walking, step activity based on daily step counts, disease severity scores, quality of life, self-efficacy on walking, and depression.
This study will utilize the breakthrough digital music therapeutic developed and manufactured by MedRhythms (Portland, ME). To examine the effects of the intervention, the investigators will use clinical measures of motor and gait function, participant self-reports on habit formation, and quantified movement data on walking and physical activity using wearable sensors. This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) Clinical Screening and Baseline Assessment, (3) Community-based, self-directed walking program (6 weeks), (3) Post-training Assessment; (4) Follow-up training (2 weeks), and (5) Final Follow-Up Assessment. Altogether, these procedures may take up to 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either intervention of (1) Amped-PD, or (2) Active-Control.
| Arm | Type | Receives |
|---|---|---|
| Amped-PD | Experimental | Device: Digital music therapeutic6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation. |
| Active-Control | Active comparator | Behavioral: Active-Control6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of idiopathic, typical Parkinson disease (based on the UK PD Society Brain Bank Criteria7) by a physician
- Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist
- 40 - 85 years of age
- Community-dwelling
- Able to walk independently without physical assistance or an assistive device for at least 10 minutes.
Key exclusion criteria (14 listed)
- < 40 years of age
- Diagnosis of atypical Parkinsonism
- Modified Hoehn and Yahr stages 4-5
- Moderately or significantly disturbing freezing episodes during daily walking based on the New Freezing of Gait Questionnaire
- History of >1 fall over the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital music therapeuticAlso: MedRhythms deviceThe digital music therapeutic 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. | Device | Amped-PD |
| Active-ControlThe Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic. | Behavioural | Active-Control |
Primary outcome
Physical Activity Based on the Amount of Moderate Intensity Walking
Time frame: Baseline
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Physical Activity Based on the Amount of Moderate Intensity Walking
Time frame: During training up to 4 days from start of training
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Physical Activity Based on the Amount of Moderate Intensity Walking
Time frame: Immediately after the intervention (up to 6 weeks)
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Physical Activity Based on the Amount of Moderate Intensity Walking
Time frame: Follow-up (up to 2 weeks post-intervention)
The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Step Activity Based on Daily Step Counts
Time frame: Baseline
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Step Activity Based on Daily Step Counts
Time frame: During training up to 4 days from start of training
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Step Activity Based on Daily Step Counts
Time frame: Immediately after the intervention (up to 6 weeks)
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Step Activity Based on Daily Step Counts
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Gait Quality Based on Variability of Stride Time
Time frame: Baseline
Stride-to-stride variability of stride time of the gait cycle will be measured using 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 percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Gait Quality Based on Variability of Stride Time
Time frame: Immediately after the intervention (up to 6 weeks)
Stride-to-stride variability of stride time of the gait cycle will be measured using 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 percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Gait Quality Based on Variability of Stride Time
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Stride-to-stride variability of stride time of the gait cycle will be measured using 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 percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Self-Report Habit Index (SRHI)
Time frame: Baseline
The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
Self-Report Habit Index (SRHI)
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
30 secondary outcomes
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Time frame: Baseline
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Time frame: Immediately after the intervention (up to 6 weeks)
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
10-Meter Walk Test (10MWT) - Maximum Walking Speed
Time frame: Baseline
10-Meter Walk Test (10MWT) - Maximum Walking Speed
Time frame: Immediately after the intervention (up to 6 weeks)
10-Meter Walk Test (10MWT) - Maximum Walking Speed
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
6-Minute Walk Test (6MWT)
Time frame: Baseline
6-Minute Walk Test (6MWT)
Time frame: Immediately after the intervention (up to 6 weeks)
6-Minute Walk Test (6MWT)
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Gait Velocity During In-clinic Walking
Time frame: Baseline
Gait Velocity During In-clinic Walking
Time frame: Immediately after the intervention (up to 6 weeks)
Gait Velocity During In-clinic Walking
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Stride Length During In-clinic Walking
Time frame: Baseline
Stride Length During In-clinic Walking
Time frame: Immediately after the intervention (up to 6 weeks)
Stride Length During In-clinic Walking
Time frame: Follow-up (up to 2 weeks post-intervention)
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
Time frame: Baseline
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
Time frame: Immediately after the intervention (up to 6 weeks)
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Self-Efficacy of Walking - Duration (SEW-D)
Time frame: Baseline
Self-Efficacy of Walking - Duration (SEW-D)
Time frame: Immediately after the intervention (up to 6 weeks)
Self-Efficacy of Walking - Duration (SEW-D)
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Geriatric Depression Scale (GDS)
Time frame: Baseline
Geriatric Depression Scale (GDS)
Time frame: Immediately after the intervention (up to 6 weeks)
Geriatric Depression Scale (GDS)
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time frame: Baseline
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time frame: Immediately after the intervention (up to 6 weeks)
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Mini Balance Evaluation Systems Test (Mini BESTest)
Time frame: Baseline
Mini Balance Evaluation Systems Test (Mini BESTest)
Time frame: Immediately after the intervention (up to 6 weeks)
Mini Balance Evaluation Systems Test (Mini BESTest)
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25858971Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Toward Understanding Ambulatory Activity Decline in Parkinson Disease. Phys Ther. 2015 Aug;95(8):1142-50. doi: 10.2522/ptj.20140498. Epub 2015 Apr 9.
- Background: PubMed 26876037Ellis TD, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Thackeray A, Thiese MS, Dibble LE. Identifying clinical measures that most accurately reflect the progression of disability in Parkinson disease. Parkinsonism Relat Disord. 2016 Apr;25:65-71. doi: 10.1016/j.parkreldis.2016.02.006. Epub 2016 Feb 2.
- Background: PubMed 24012774Nombela C, Hughes LE, Owen AM, Grahn JA. Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3.
- Background: PubMed 8684391Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Mov Disord. 1996 Mar;11(2):193-200. doi: 10.1002/mds.870110213.
- Background: PubMed 33040685Hutchinson K, Sloutsky R, Collimore A, Adams B, Harris B, Ellis TD, Awad LN. A Music-Based Digital Therapeutic: Proof-of-Concept Automation of a Progressive and Individualized Rhythm-Based Walking Training Program After Stroke. Neurorehabil Neural Repair. 2020 Nov;34(11):986-996. doi: 10.1177/1545968320961114. Epub 2020 Oct 10.
- Background: PubMed 25207647Gardner B. A review and analysis of the use of 'habit' in understanding, predicting and influencing health-related behaviour. Health Psychol Rev. 2015;9(3):277-95. doi: 10.1080/17437199.2013.876238. Epub 2014 Jan 21.
- Background: PubMed 25643222Galla BM, Duckworth AL. More than resisting temptation: Beneficial habits mediate the relationship between self-control and positive life outcomes. J Pers Soc Psychol. 2015 Sep;109(3):508-25. doi: 10.1037/pspp0000026. Epub 2015 Feb 2.
- Background: PubMed 32083083Wittwer JE, Winbolt M, Morris ME. Home-Based Gait Training Using Rhythmic Auditory Cues in Alzheimer's Disease: Feasibility and Outcomes. Front Med (Lausanne). 2020 Jan 31;6:335. doi: 10.3389/fmed.2019.00335. eCollection 2019.
- Background: PubMed 32255504Jeng B, Cederberg KL, Lai B, Sasaki JE, Bamman MM, Motl RW. Step-rate threshold for physical activity intensity in Parkinson's disease. Acta Neurol Scand. 2020 Aug;142(2):145-150. doi: 10.1111/ane.13250. Epub 2020 Apr 22.
- Background: PubMed 21798044Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.
- Derived from this study: PubMed 40438970Cavanaugh 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.
- Derived from this study: PubMed 40301366Porciuncula 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franchino Porciuncula, PT, EdD principal investigator
Boston University
Terry D. Ellis, PT, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital music therapeutic in people with Parkinson Disease, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Based on the Amount of Moderate Intensity Walking (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05421624, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.