Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT05337982
Status
Recruiting
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Conditions

  • Healthy
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Downhill Eccentric Treadmill Training with Electrical Stimulation — OTHER
    Participants will walk on a treadmill with a downward incline with support from a harness and assistance from trainers as needed. Participants will also simultaneously receive stimulation to their muscles including their trunk and legs. Each session will include 20 minutes of walking divided into 5 minute bouts with 5 minute rest breaks in between for 3 sessions per week for 12 weeks.

Study Details

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.

Key Dates

Start date
May 17, 2022
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
49 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCI Go
    Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately.
  • Experimental: SCI No Go
    Participants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months.
  • No Intervention: SCI SOC
    Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy.
  • No Intervention: Healthy Control
    Healthy controls will provide biomarker and/or myelin (MRI) data

Primary Outcome Measure

Change from baseline in electromyography of eccentric acting muscles [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Michele Basso, EdD, PT
[email protected]
614-814-1404
Michele Basso, EdD (PRINCIPAL_INVESTIGATOR)

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By research site
The Ohio State University· Columbus, OH

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