Amplifying walking activity in Parkinson's disease through autonomous music-based rhythmic auditory stimulation: randomized controlled trial

Abstract

Habitual moderate intensity walking has disease-modifying benefits in Parkinson's disease (PD). However, the lack of sustainable gait interventions that collectively promote sufficient intensity, daily amount, and quality of walking marks a critical gap in PD rehabilitation. In this randomized controlled trial (clinicaltrials.gov#: NCT05421624, registered on June 6, 2022), we demonstrate the effectiveness of a real-world walking intervention delivered using an autonomous music-based digital rhythmic auditory stimulation (RAS) system. In comparison to an active-control arm (N = 20) of moderately intense brisk walking, the autonomous RAS system used in the experimental arm (N = 21) amplified moderate-to-vigorous walking intensities, increased daily steps, and improved (reduced) gait variability. While regular engagement in real-world walking with or without RAS each cultivated habits for walking, only the RAS intervention yielded a combination of strengthened habits and improved gait outcomes. Findings from this study supported the use of a personalized, autonomous RAS gait intervention that is effective, habit-forming and translatable to real-world walking in individuals with PD.

Fig. 1. Study CONSORT diagram.

A flow chart summarizing participant enrollment, allocation, follow-up, and analysis, with detail on reasons for exclusion at each stage in the clinical trial.

Fig. 2. Flow diagram of assessment timepoints.

Real-world step assessment (moderate intensity minutes, daily steps) was performed at Baseline, during the intervention, during the follow-on period and at post-program completion. In-lab clinical assessments of gait stride time variability (STV) were performed at Baseline, Post 6-Week Assessment, and Post-8-Week Assessment. Self-reports of habit for “walking for exercise” were obtained at baseline and Post-8-week Assessment.

Fig. 3. Effects of Amped-PD and Active-Control interventions on daily minutes of moderate intensity walking.

a Between-group comparisons on changes in moderate intensity walking. b Within-subject comparisons on moderate intensity walking by group. Red bars refer to Amped-PD. Gray bars refer to Active-Control. Blue dashed line denotes 30 min of moderate intensity walking, consistent with public health recommendations for adults with chronic conditions (e.g. daily 30-min moderate intensity aerobic activity). Data are presented as mean ± standard deviation.

Fig. 4. Effects of Amped-PD and Active-Control interventions on daily walking based on walking amount (step counts).

a Between-group comparisons on changes in daily step counts. b Within-subject comparisons on daily step counts by group. Red bars refer to Amped-PD. Gray bars refer to Active-Control. Blue dashed line denotes minimum detectable change (MDC) in daily steps relative to baseline. Values equal or greater than the MDC line signify change in daily steps that is greater than measurement error. Data are presented as mean ± standard deviation.

Fig. 5. Effects of Amped-PD and Active-Control interventions on stride time variability (STV).

a Between-group comparisons on changes in STV. b Within-subject comparisons of STV by group. c Individual response analyses of STV. Lower STV values are indicative of improvement in gait variability, while higher STV values are indicative of worse gait variability. Blue dashed lines mark the threshold for minimum clinically important difference (MCID) of −0.67%CoV. Reductions in STV equal to or lower than the MCID are considered clinically meaningful. Data for (a, b) are presented as mean ± standard deviation, and data for (c) are individual participant responses.

Fig. 6. Effects of intervention on Self-Report Habit Index (SRHI).

a Between-group comparisons of change in SRHI scores. b Within-subject comparisons of SRHI scores by group. c Relationship of SRHI and total amount of walking sessions with groups collapsed. Red bars refer to Amped-PD. Gray bars refer to Active-Control. Data for (a, b) are presented as mean ± standard deviation, and data in (c) (green scatter dots) represent each data point across both groups.

Fig. 7. User experience with Amped-PD intervention.

Thematic data from interview of participants in Amped-PD group.

Fig. 8. Overview of MR-005 closed-loop digital RAS system and the Amped-PD Intervention.

a Components of MR-005 autonomous rhythmic auditory stimulation system. b Instructions on independent use of MR-005 system. c Self-managed real-world walking program. Informed consent was obtained for the use of participant images in the figure.