15 Participants NeededMy employer runs this trial

Rhythmic Auditory Stimulation for Spinal Cord Injury

AM
SS
Overseen ByShane Stone, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SS

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

Language: English or Spanish only
Able to consent
I can walk with minimal help from another person.
See 4 more

Exclusion Criteria

I need a KAFO brace to walk.
Unable to perceive music through the MedRhythyms device
I have other medical or neurological conditions that cause weakness.
See 2 more

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

Group I: Rhythmic Auditory StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+