Recruiting

Eccentric Muscle Training

Sponsor:

Ohio State University

Code:

NCT05337982

Conditions

Spinal Cord Injuries

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Downhill Eccentric Treadmill Training with Electrical Stimulation

Study Details

Brief summary:

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

Spinal Cord Injuries

Healthy

Study ID

NCT05337982

Start date

May 17, 2022

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

INCLUSION CRITERIA:

SCI participants WITHIN 1-5 MONTHS OF THEIR INJURY:

  • Discharged from inpatient rehabilitation;
  • AIS A-D at neurologic level C1-T10;
  • 18-85 years old.

Healthy controls:

  • Adults 18-85 years old;
  • no recent major musculoskeletal injury;
  • no recent surgery.

EXCLUSION CRITERIA:

SCI participants:

  • Use of botox in the past 3 months that reduces skeletal muscle function;
  • other neurologic conditions (i.e. brain injury, stroke, HIV);
  • current cancer diagnosis;
  • active deep vein thrombosis and anti-coagulation therapy;
  • skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training.
  • pregnancy;
  • ventilator-dependence;
  • cognitive conditions that preclude providing informed consent.
  • Implanted medical devices that are contraindicated for electrical stimulation or MRI \*(If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.)

Healthy controls:

  • Implanted medical devices that are contraindicated for MRI (MRI participants only);
  • neurologic conditions (i.e. brain injury, stroke, HIV);
  • current cancer diagnosis;
  • clotting disorders requiring anti-coagulation therapy;
  • inflammatory conditions like arthritis, ulcerative colitis, lupus, etc;
  • pregnancy;
  • fear of needles;
  • claustrophobia;
  • cognitive conditions that preclude providing informed consent.

Study Design

Enrollment

49 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Downhill Eccentric Treadmill Training with Electrical Stimulation

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.

Primary outcome measure

  • Change from baseline in electromyography of eccentric acting muscles [ Time Frame: 12 weeks ]
  • Change from baseline in kinetics during weight acceptance [ Time Frame: 12 weeks ]
  • Change from baseline in kinematics during weight acceptance: hip range of motion [ Time Frame: 12 weeks ]
  • Change from baseline in kinematics during weight acceptance: knee range of motion [ Time Frame: 12 weeks ]
  • Change from baseline in kinematics during weight acceptance: ankle range of motion [ Time Frame: 12 weeks ]
  • Change from baseline in kinematics during weight acceptance: hip acceleration [ Time Frame: 12 weeks ]
  • Change from baseline in kinematics during weight acceptance: knee acceleration [ Time Frame: 12 weeks ]
  • Change from baseline in kinematics during weight acceptance: ankle acceleration [ Time Frame: 12 weeks ]
  • Change from baseline in myelination in brain and spinal cord measured by Magnetic Resonance Imaging (MRI) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Michele Basso, EdD, PT

614-814-1404michele.basso@osumc.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Michele Basso, EdD, PT

614-814-1404michele.basso@osumc.edu

Principal Investigator:

Michele Basso, EdD

University of British Columbia

Recruiting

Vancouver, Canada

Contacts

Lara Boyd

lara.boyd@ubc.ca

More Information

Sponsor

Ohio State University

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • Spinal Cord Injury
  • SCI
  • Biomarkers
  • MRI
  • Locomotor Training
  • Downhill
  • Neuromodulation
  • Electrical Stimulation
  • CSF
  • Rehabilitation
  • Physical Therapy
  • Eccentric
  • Treadmill
  • blood draw

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-12-23.