Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

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.
    

Intervention name(s): Digital music therapeutic; Active-Control
Intervention type(s): Device; Behavioral
Intervention description(s): 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.; The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
Other intervention name(s): MedRhythms device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to either intervention of (1) Amped-PD, or (2) Active-Control.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson disease; rhythmic auditory stimulation; digital therapeutics; behavior change; habits; physical activity