NCT07674927 Pilot Study Exploring the Effects of Rhythmic Auditory Stimulation on Gait in People With Motor Incomplete Spinal Cord Injury
| NCT ID | NCT07674927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2026-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Shane Stone, MD
PRINCIPAL INVESTIGATOR
UC Davis
Frequently Asked Questions
Who can join the NCT07674927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07674927 currently recruiting?
Yes, NCT07674927 is actively recruiting participants. Contact the research team at amshammee@health.ucdavis.edu for enrollment information.
Where is the NCT07674927 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT07674927 clinical trial?
NCT07674927 is sponsored by University of California, Davis. The principal investigator is Shane Stone, MD at UC Davis. The trial plans to enroll 15 participants.