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

NCT07674927 | Recruiting FDA Device

• 1 other identifier: 2352022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 10-Meter Walk Test (10MWT)

  Measure of speed

  Baseline, post-intervention at 6 weeks and follow-up at 12 weeks

Secondary Outcomes (1)

• 6-Minute Walk Test (6MWT)

  baseline, post-intervention at 6 weeks, and follow-up at 12 weeks

Study Arms (1)

Rhythmic Auditory Stimulation

EXPERIMENTAL

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

Device: rhythmic auditory stimulation

Interventions

rhythmic auditory stimulation DEVICE

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)

Rhythmic Auditory Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Point West

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Shane Stone, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita M Shammee, DO

CONTACT

15712056604; amshammee@health.ucdavis.edu

Shane Stone, MD

CONTACT

snstone@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)