Spinal Cord InjuryNCT07674927
Pilot Study Exploring the Effects of Rhythmic Auditory Stimulation on Gait in People With Motor Incomplete Spinal Cord Injury
A study testing rhythmic auditory stimulation in people with Spinal Cord Injury, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- rhythmic auditory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shane Stone, MD contact
United States1 site, 1 recruiting
- Recruiting
UC Davis Point West
Sacramento, California, 95817
Anita Shammee, DO, 571-205-6604, amshammee@health.ucdavis.edu
About this study
Official title: Exploring the Effects of Rhythmic Auditory Stimulation on Gait in Motor Incomplete Spinal Cord Injury: A Pilot Study
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
- Being tested
- rhythmic auditory stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhythmic auditory stimulationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: rhythmic auditory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Meter Walk Test (10MWT)
Measure of speed
Measured: Baseline, post-intervention at 6 weeks and follow-up at 12 weeks
Secondary outcomes (1)
6-Minute Walk Test (6MWT)
measure of endurance
Measured: baseline, post-intervention at 6 weeks, and follow-up at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shane Stone, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674927
- Sponsor's protocol ID
- 2352022
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Rhythmic Auditory Stimulation on Gait in Motor Incomplete Spinal Cord Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT07674927
- Acronym / sponsor ID
- 2352022
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Auditory Stimulation | Experimental | Device: rhythmic auditory stimulationParticipants will wear a rhythmic auditory stimulation device (MedRhythms) for 30 minutes during physical therapy sessions twice a week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhythmic auditory stimulationThe 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) | Device | Rhythmic Auditory Stimulation |
Primary outcome
10-Meter Walk Test (10MWT)
Time frame: Baseline, post-intervention at 6 weeks and follow-up at 12 weeks
Measure of speed
1 secondary outcome
6-Minute Walk Test (6MWT)
Time frame: baseline, post-intervention at 6 weeks, and follow-up at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shane Stone, MD contact
Shane Stone, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhythmic auditory stimulation in people with Spinal Cord Injury, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita M Shammee, DO (15712056604, amshammee@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-Meter Walk Test (10MWT) (time frame: Baseline, post-intervention at 6 weeks and follow-up at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.