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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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)

Recruiting Locations

UC Davis Point West
Sacramento, California 95817
Contact:
Anita Shammee, DO
571-205-6604
amshammee@health.ucdavis.edu

More Details

Status
Recruiting
Sponsor
University of California, Davis

Study Contact

Anita M Shammee, DO
15712056604
amshammee@health.ucdavis.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.