Recruiting

MedRhythms

Sponsor:

UCLA

Code:

NCT07674927

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

rhythmic auditory stimulation

Study Details

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.

Conditions

Spinal Cord Injury

Study ID

NCT07674927

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Rhythmic Auditory Stimulation

Participants will wear a rhythmic auditory stimulation device (MedRhythms) for 30 minutes during physical therapy sessions twice a week for 6 weeks.

Interventions

rhythmic auditory stimulation

The purpose of this study is to evaluate the feasibility and preliminary efficacy of a rhythmic auditory stimulation device (MedRhythms) in improving gait parameters in individuals with chronic, incomplete spinal cord injury (SCI). Participants will train with the device in a supervised, in-clinic setting at Point West Clinic for 6 weeks, completing 2 sessions per week (12 sessions total)

Primary outcome measure

  • 10-Meter Walk Test (10MWT) [ Time Frame: Baseline, post-intervention at 6 weeks and follow-up at 12 weeks ]

Central Contacts and Locations

Central contacts

Anita M Shammee, DO

15712056604amshammee@health.ucdavis.edu

Shane Stone, MD

snstone@health.ucdavis.edu

Locations

UC Davis Point West

Recruiting

Sacramento, California, United States, 95817

Contacts

Anita Shammee, DO

571-205-6604amshammee@health.ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-06-30.