Pilot Study Exploring the Effects of Rhythmic Auditory St... | NCT07674927

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

NCT07674927

Sponsor

University of California, Davis

Status

Recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Spinal Cord Injury

Interventions

rhythmic auditory stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jun 23, 2026

First Submission Date that Met QC Criteria

Jun 23, 2026

First Posted Date

Jun 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2026

Last Update Posted Date

Jun 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
10-Meter Walk Test (10MWT)	Measure of speed	Baseline, post-intervention at 6 weeks and follow-up at 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
6-Minute Walk Test (6MWT)	measure of endurance	baseline, post-intervention at 6 weeks, and follow-up at 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anita M Shammee, DO	Contact	15712056604		amshammee@health.ucdavis.edu
Shane Stone, MD	Contact			snstone@health.ucdavis.edu

Overall Officials

Name	Affiliation	Role
Shane Stone, MD	UC Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Point West	Recruiting	Sacramento	California	95817	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided