Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease

Parkinson Disease Clinical Trial

— Amped-PD  

Official title:

Amped-PD: Amplifying Physical Activity Through a Novel Digital Music Therapeutic in Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421624
• Other study ID #: 6518
• Secondary ID: P30AG048785
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: April 2024
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• < 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)

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Digital music therapeutic
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.

Behavioral:
• Active-Control
The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.

Locations

Country	Name	City	State
United States	Center for Neurorehabilitation at Boston University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Aging (NIA), University of New England

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Ellis 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. — View Citation

Galla 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. — View Citation

Gardner 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. — View Citation

Hutchinson 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. — View Citation

Jeng 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. — View Citation

Nombela 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. — View Citation

Thaut 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. — View Citation

Tudor-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. — View Citation

Wittwer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	During training up to 4 days from start of training
Primary	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.	Immediately after the intervention (up to 6 weeks)
Primary	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.	Follow-up (up to 2 weeks post-intervention)
Primary	Gait quality based on variability of stride length	Stride-to-stride variability of stride lengthof the gait cycle will be measured using wearable sensors.	Baseline
Primary	Gait quality based on variability of stride length	Stride-to-stride variability of stride length of the gait cycle will be measured using wearable sensors.	Immediately after the intervention (up to 6 weeks)
Primary	Gait quality based on variability of stride length	Stride-to-stride variability of stride length of the gait cycle will be measured using wearable sensors.	Follow-up (up to 2 weeks post-intervention)
Primary	Gait quality based on variability of swing time	Stride-to-stride variability of swing time subphase of the gait cycle will be measured using wearable sensors.	Baseline
Primary	Gait quality based on variability of swing time	Stride-to-stride variability of swing time subphase of the gait cycle will be measured using wearable sensors.	Immediately after the intervention (up to 6 weeks)
Primary	Gait quality based on variability of swing time	Stride-to-stride variability of swing time subphase of the gait cycle will be measured using wearable sensors.	Follow-up (up to 2 weeks post-intervention)
Primary	Self-Report Behavioral Automaticity Index (SRBAI)	The Self-Report Behavioral Automaticity Index (SRBAI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit automaticity. 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). Select items from this test make up the Self-Report Habit Index, which examines strength and automaticity of habits.	Baseline
Primary	Self-Report Behavioral Automaticity Index (SRBAI)	The Self-Report Behavioral Automaticity Index (SRBAI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit automaticity. 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). Select items from this test make up the Self-Report Habit Index, which examines strength and automaticity of habits.	Immediately after the intervention (up to 6 weeks)
Primary	Self-Report Behavioral Automaticity Index (SRBAI)	The Self-Report Behavioral Automaticity Index (SRBAI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit automaticity. 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). Select items from this test make up the Self-Report Habit Index, which examines strength and automaticity of habits.	Follow-up (up to 2 weeks post-intervention)
Secondary	10-Meter Walk Test (10MWT)	This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.	Baseline
Secondary	10-Meter Walk Test (10MWT)	This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.	Immediately after the intervention (up to 6 weeks)
Secondary	10-Meter Walk Test (10MWT)	This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.	Follow-up (up to 2 weeks post-intervention)
Secondary	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.	Baseline
Secondary	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.	Immediately after the intervention (up to 6 weeks)
Secondary	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.	Follow-up (up to 2 weeks post-intervention)
Secondary	Walking cadence during in-clinic walking	Quantified metrics of walking cadence (steps/min) will be collected using wearable sensors.	Baseline
Secondary	Walking cadence during in-clinic walking	Quantified metrics of walking cadence (steps/min) will be collected using wearable sensors.	Immediately after the intervention (up to 6 weeks)
Secondary	Walking cadence during in-clinic walking	Quantified metrics of walking cadence (steps/min) will be collected using wearable sensors.	Follow-up (up to 2 weeks post-intervention)
Secondary	Gait velocity during in-clinic walking	Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.	Baseline
Secondary	Gait velocity during in-clinic walking	Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.	Immediately after the intervention (up to 6 weeks)
Secondary	Gait velocity during in-clinic walking	Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.	Follow-up (up to 2 weeks post-intervention)
Secondary	Stride length during in-clinic walking	Quantified metrics of stride length (m) will be collected using wearable sensors.	Baseline
Secondary	Stride length during in-clinic walking	Quantified metrics of stride length (m) will be collected using wearable sensors.	Immediately after the intervention (up to 6 weeks)
Secondary	Stride length during in-clinic walking	Quantified metrics of stride length (m) will be collected using wearable sensors.	Follow-up (up to 2 weeks post-intervention)
Secondary	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.	Baseline
Secondary	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.	During training up to 4 days from start of training
Secondary	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.	Immediately after the intervention (up to 6 weeks)
Secondary	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.	Follow-up (up to 2 weeks post-intervention)
Secondary	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. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.	Baseline
Secondary	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. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.	Immediately after the intervention (up to 6 weeks)
Secondary	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. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.	Follow-up (up to 2 weeks post-intervention)
Secondary	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).	Baseline
Secondary	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).	Immediately after the intervention (up to 6 weeks)
Secondary	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).	Follow-up (up to 2 weeks post-intervention)
Secondary	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).	Baseline
Secondary	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).	Immediately after the intervention (up to 6 weeks)
Secondary	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).	Follow-up (up to 2 weeks post-intervention)
Secondary	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).	Baseline
Secondary	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).	Immediately after the intervention (up to 6 weeks)
Secondary	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).	Follow-up (up to 2 weeks post-intervention)
Secondary	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. The test has a maximum score of 28, with each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function).	Baseline
Secondary	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. The test has a maximum score of 28, with each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function).	Immediately after the intervention (up to 6 weeks)
Secondary	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. The test has a maximum score of 28, with each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function).	Follow-up (up to 2 weeks post-intervention)