Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT05337982

Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

Led by Ohio State University · Updated on 2025-12-23

49

Participants Needed

2

Research Sites

241 weeks

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

U

University of Notre Dame

Collaborating Sponsor

AI-Summary

What this Trial Is About

The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. This will include checking for certain features called biomarkers by testing participants' spinal fluid and blood and compare these features to individuals without SCI. These features will help investigators determine when to start the new training program, either right away or waiting for 3 months. The new training program uses walking downhill on a slight slope on a treadmill while muscles that are not working normally are stimulated to contract using low levels of electricity. Adding this stimulation will allow people to practice walking and other skills even though full muscle control has not recovered. This new program will be in addition to any other rehabilitation therapy and will not replace standard rehabilitation. The hope is to see if downhill training with muscle stimulation, when delivered at the most ideal time, will improve trunk and leg movement, walking, and overall function. This recovery of movement and function will be compared to people with SCI receiving standard rehabilitation alone. Certain regions of the brain and spinal cord will also be studied using MRI scans to determine if these are affected by the training and compare to individuals without SCI. The total length of the study for SCI participants will be up to 16 weeks if in the standard of care group and up to 33 weeks if in the trained group. Healthy control participants will be involved for 1-2 visits.

CONDITIONS

Official Title

Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • SCI participants discharged from inpatient rehabilitation within 1-5 months after injury
  • Neurologic level of injury between C1 and T10 with AIS grade A-D
  • Age between 18 and 85 years
  • Healthy controls aged 18 to 85 years
  • Healthy controls with no recent major musculoskeletal injury or surgery
Not Eligible

You will not qualify if you...

  • SCI participants who used botox in the past 3 months that reduces skeletal muscle function
  • SCI participants with other neurologic conditions such as brain injury, stroke, or HIV
  • SCI participants with current cancer diagnosis
  • SCI participants with active deep vein thrombosis receiving anti-coagulation therapy
  • SCI participants with skin wounds interfering with harness, stimulation, or hand placement during training
  • SCI participants who are pregnant
  • SCI participants who are ventilator-dependent
  • SCI participants with cognitive impairments preventing informed consent
  • SCI participants with implanted medical devices contraindicated for electrical stimulation or MRI (MRI contraindicated participants may still participate except for myelin outcome measures)
  • Healthy controls with implanted medical devices contraindicated for MRI (if participating in MRI)
  • Healthy controls with neurologic conditions such as brain injury, stroke, or HIV
  • Healthy controls with current cancer diagnosis
  • Healthy controls with clotting disorders needing anti-coagulation therapy
  • Healthy controls with inflammatory conditions like arthritis, ulcerative colitis, lupus
  • Healthy controls who are pregnant
  • Healthy controls with fear of needles
  • Healthy controls with claustrophobia
  • Healthy controls with cognitive impairments preventing informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

2

University of British Columbia

Vancouver, Canada

Actively Recruiting

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Research Team

M

Michele Basso, EdD, PT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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