Pilot Study Exploring the Effects of Rhythmic Auditory Stimulation on Gait in People With Motor I… (NCT07674927) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study Exploring the Effects of Rhythmic Auditory Stimulation on Gait in People With Motor Incomplete Spinal Cord Injury
United States15 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
10-Meter Walk Test (10MWT)
Timeframe: Baseline, post-intervention at 6 weeks and follow-up at 12 weeks