Rhythmic Auditory Stimulation for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Index for Spinal Cord Injury II (WISCI II) and the SCI Quality of Life Satisfaction with Social Roles and Activities measure. Outcomes will be assessed at baseline, post-intervention (6 weeks), and follow-up (12 weeks).
Findings from this study will provide preliminary data on the feasibility and potential clinical impact of rhythmic auditory stimulation as an adjunctive gait rehabilitation strategy for individuals with incomplete SCI.
Who Is on the Research Team?
Shane Stone, MD
Principal Investigator
UC Davis
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who have a non-progressive, motor incomplete spinal cord injury. Participants should be able to walk with some assistance and attend regular physical therapy sessions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- MedRhythms rhythmic auditory stimulation system
Trial Overview
The study tests a wearable device called MedRhythms that uses shoe sensors and headphones to give rhythmic sounds while walking. The goal is to see if these sounds can help improve walking speed and endurance in people with incomplete spinal cord injuries over six weeks of supervised training.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will wear a rhythmic auditory stimulation device (MedRhythms) for 30 minutes during physical therapy sessions twice a week for 6 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
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