Clinical trial NCT05421624: Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease
Official title: Amped-PD: Amplifying Physical Activity Through a Novel Digital Music Therapeutic in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
rhythmic auditory stimulation
digital therapeutics
behavior change
habits
physical activity
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of New England
name: National Institute on Aging (NIA)
First posted: 2022-06-16
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either intervention of (1) Amped-PD, or (2) Active-Control.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity Based on the Amount of Moderate Intensity Walking
timeFrame: Baseline
measure: Physical Activity Based on the Amount of Moderate Intensity Walking
timeFrame: During training up to 4 days from start of training
measure: Physical Activity Based on the Amount of Moderate Intensity Walking
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Physical Activity Based on the Amount of Moderate Intensity Walking
timeFrame: Follow-up (up to 2 weeks post-intervention)
measure: Step Activity Based on Daily Step Counts
timeFrame: Baseline
measure: Step Activity Based on Daily Step Counts
timeFrame: During training up to 4 days from start of training
measure: Step Activity Based on Daily Step Counts
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Step Activity Based on Daily Step Counts
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Gait Quality Based on Variability of Stride Time
timeFrame: Baseline
measure: Gait Quality Based on Variability of Stride Time
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Gait Quality Based on Variability of Stride Time
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Self-Report Habit Index (SRHI)
timeFrame: Baseline
measure: Self-Report Habit Index (SRHI)
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Secondary outcomes:
measure: 10-Meter Walk Test (10MWT) - Comfortable Walking Speed
timeFrame: Baseline
measure: 10-Meter Walk Test (10MWT) - Comfortable Walking Speed
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: 10-Meter Walk Test (10MWT) - Comfortable Walking Speed
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: 10-Meter Walk Test (10MWT) - Maximum Walking Speed
timeFrame: Baseline
measure: 10-Meter Walk Test (10MWT) - Maximum Walking Speed
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: 10-Meter Walk Test (10MWT) - Maximum Walking Speed
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: 6-Minute Walk Test (6MWT)
timeFrame: Baseline
measure: 6-Minute Walk Test (6MWT)
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: 6-Minute Walk Test (6MWT)
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Gait Velocity During In-clinic Walking
timeFrame: Baseline
measure: Gait Velocity During In-clinic Walking
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Gait Velocity During In-clinic Walking
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Stride Length During In-clinic Walking
timeFrame: Baseline
measure: Stride Length During In-clinic Walking
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Stride Length During In-clinic Walking
timeFrame: Follow-up (up to 2 weeks post-intervention)
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
timeFrame: Baseline
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Self-Efficacy of Walking - Duration (SEW-D)
timeFrame: Baseline
measure: Self-Efficacy of Walking - Duration (SEW-D)
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Self-Efficacy of Walking - Duration (SEW-D)
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Geriatric Depression Scale (GDS)
timeFrame: Baseline
measure: Geriatric Depression Scale (GDS)
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Geriatric Depression Scale (GDS)
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Parkinson's Disease Questionnaire - 39 (PDQ-39)
timeFrame: Baseline
measure: Parkinson's Disease Questionnaire - 39 (PDQ-39)
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Parkinson's Disease Questionnaire - 39 (PDQ-39)
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
measure: Mini Balance Evaluation Systems Test (Mini BESTest)
timeFrame: Baseline
measure: Mini Balance Evaluation Systems Test (Mini BESTest)
timeFrame: Immediately after the intervention (up to 6 weeks)
measure: Mini Balance Evaluation Systems Test (Mini BESTest)
timeFrame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Neurorehabilitation at Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Franchino Porciuncula, PT, EdD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Terry D. Ellis, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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