A Pilot Randomized Waitlist-Controlled Study of Home-Based Rhythmic Auditory Stimulation to Evaluate Mobility, Balance, and Patient-Reported Outcomes After Traumatic Brain Injury

1. PURPOSE, BACKGROUND, SCIENTIFIC RATIONALE Traumatic brain injury (TBI) affects approximately 2.8 million people annually in the United States and remains a major public health concern due to its high rates of disability and long-term functional impairment.1 TBI commonly results from falls, motor vehicle collisions, sports -related injuries, and assaults, and can lead to persistent deficits in mobility, balance, cognition, and overall functional independence.2 Even after acute recovery, many individuals experience prolonged limitations that interfere with community participation and quality of life.3,4 As survival rates improve, optimizing rehabilitation strategies that support functional recovery has become increasingly important.

Impaired mobility and balance are two common long-term sequelae of TBI5-7 that have substantial negative life impacts and often persist for years post injury.8 Individuals with TBI walk more slowly,9-13 demonstrate greater imbalance,11-13 and have reduced endurance14 compared to nondisabled counterparts; evidence suggests that improving mobility and balance after TBI is associated with improved quality of life and community participation.15 Despite clinical guidelines emphasizing the importance of ongoing, task-specific rehabilitation to promote neuroplasticity, access to sustained outpatient therapy for individuals with chronic TBI is limited by cost, transportation barriers, workforce constraints, and insurance coverage.16 As a result, there is a critical need for scalable, home-based rehabilitation approaches that can safely deliver high-quality, progressive mobility training while supporting adherence and engagement over time.

Rhythmic auditory stimulation (RAS) is a well established, evidence based neuromodulation approach that uses rhythmic auditory cues, such as music, to synchronize and support motor activity through auditory-motor entrainment..17,18 This synchronization can enhance gait neuromotor control by activating intact motor networks to facilitate recovery after neurologic injury.19,20 Stroke literature demonstrates that RAS improves walking speed, cadence, symmetry, endurance, and functional mobility, with emerging evidence that music-based cueing may also enhance motivation, enjoyment, and engagement relative to metronome-only cueing.17 A growing body of literature suggests that music-based interventions may offer multi-domain benefits for individuals with TBI, extending beyond motor recovery to cognitive, emotional, and psychosocial outcomes.21,22 Randomized controlled trials of neurological music therapy in moderate-to-severe TBI have demonstrated improvements in executive function, behavioral regulation, and attentional control.22,23 Complementary neuroimaging analyses provide preliminary evidence that these functional gains may be supported by music-induced neuroplasticity, including structural and network-level changes within prefrontal and frontotemporal circuits implicated in cognitive control and emotional regulation. Systematic reviews further indicate that music-based interventions are associated with improvements in mood, agitation, stress, social interaction, and sleep quality in TBI populations, supporting their potential relevance for quality-of-life outcomes. However, despite these promising findings, the evidence base remains limited by small sample sizes, heterogeneous intervention protocols, variable outcome measures, and inconsistent reporting of dose, timing, and treatment fidelity. Recent reviews emphasize the need for larger, methodologically rigorous trials with standardized outcomes and clearer mechanistic frameworks to support translation into routine neurorehabilitation practice.

MedRhythms' MR-001 represents a significant advancement in the delivery of RAS. The system integrates wearable inertial sensors with proprietary, closed-loop algorithms to autonomously deliver individualized, progressive, music-based rhythmic cueing during walking in the home environment. Specifically, the MR-001 neurorehabilitation system consists of three components: two shoe-worn wearable inertial sensors that measure walking patterns and gait parameters in real time, a bluetooth headset to deliver RAS via music, and a touchscreen control unit preloaded with intervention software to deliver personalized therapy. The MR-001 neurorehabilitation system continuously assesses the user's entrainment to the target tempo and evaluates gait symmetry and variability, while safely and autonomously adjusting the target walking speed without direct clinician input.

Unlike traditional RAS approaches that require in-person clinician oversight, this technology adapts tempo and cueing in real time based on gait quality and entrainment, enabling safe, unsupervised home use. A large-scale study (n=204) in the stroke population provides strong preliminary evidence supporting the feasibility, safety, and effectiveness of this approach. In the OrcHESTRAS single arm, pragmatic home-based trial, over 81.9% (95% confidence interval [CI] 0.76-0.87) achieved moderate to high weekly use > 4 weeks meeting the primary endpoint (p<0.001) over 12 weeks, exceeding the predefined feasibility benchmark of 60%. Additionally, participants demonstrated significant improvements in walking endurance (6-minute walk test [6minWT] 26.1 ± 5.6m; 95% CI 14.99, 37.22) and functional mobility (Timed Up and Go [TUG] -1.45 ± 0.31s; 95% CI -2.06, -0.84 p< 0.001). Weekly use influenced effectiveness with each additional week of use predicting a 5.82m greater gain in the 6minWT (standard error [SE] = 2.05; 95% CI 1.77, 9.87], p<0.005. Importantly, the intervention exhibited an acceptable safety profile across more than 100,000 minutes of autonomous use, with adverse events and falls largely consistent with baseline risk in chronic stroke populations (preprint doi.org/10.64898/2026.03.13.26348352)