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Pilot Study Exploring the Effects of Rhythmic Auditory Stimulation on Gait in People With Motor Incomplete Spinal Cord Injury

RecruitingNAAges 18 Years - anyAllUniversity of California, Davis
NCT07674927 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This pilot study aims to evaluate the feasibility and preliminary efficacy of a wearable rhythmic auditory stimulation system, MedRhythms, for improving gait parameters in patients with motor incomplete SCI. Up to 15 participants aged 18 years or older with non-progressive SCI will be enrolled. Participants will complete supervised gait training using the MedRhythms device twice weekly during regularly scheduled physical therapy sessions over a six-week period. The device uses shoe-mounted sensors and headphones to deliver real-time individualized rhythmic auditory cues based on the user's gait pattern. Primary outcome measures include change in walking speed assessed with the 10-Meter Walk Test. Secondary outcomes include walking endurance measured by the 6-Minute Walk Test, gait parameters obtained through GAITRite analysis, and participant-reported outcomes including the Walking Inde

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years old * Language: English or Spanish only * Diagnosis: non-progressive spinal cord lesion; classification as either grade C, D, or E SCI based on American Spinal Injury Association (ASIA) Impairment Scale (AIS) * Able to ambulate at least a contact guard assist level * Time post injury: ≥6 months * Cadence: minimum 40 steps/minute with clear heel strike * Able to consent Exclusion Criteria: * Individuals who use an assistive device and are unable to achieve a 2-point walking pattern (left-right-left-right) with an assistive device * Walks exclusively with a 3-point walking pattern with an assistive device * Ambulation requiring a knee-ankle-foot orthosis (KAFO) * Presence of additional neurological or medical processes that contribute to weakness * Unable to perceive music through the MedRhythyms device
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What it tests

  • rhythmic auditory stimulation
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Where

1 site
UC Davis Point West
Sacramento, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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