New rehabilitation approach for walking recovery after spinal cord injury

Eccentric Motor Training With Neuromodulation and Biomarkers for Rehabilitation Readiness in Subacute SCI

This study is testing a new rehab program that combines downhill treadmill training and electrical stimulation to see if it helps people with spinal cord injuries walk better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 2 sites (Columbus, Ohio and 1 other locations)
• Trial ID: NCT05337982 on ClinicalTrials.gov

What this trial studies

This study investigates a novel rehabilitation treatment aimed at helping individuals recover their ability to walk following a spinal cord injury (SCI). Participants will be divided into two groups: one receiving standard care and the other undergoing a specialized program that combines downhill treadmill training with electrical stimulation. The study will analyze biomarkers in blood and spinal fluid to determine the optimal timing for initiating this new training regimen. The goal is to enhance rehabilitation outcomes by allowing patients to practice walking even when full muscle control has not yet returned.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-85 who are within 1-5 months post spinal cord injury and have been discharged from inpatient rehabilitation.

Not a fit: Patients with other neurological conditions, recent major musculoskeletal injuries, or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking recovery for individuals with spinal cord injuries.

How similar studies have performed: While the specific combination of interventions in this study is novel, similar rehabilitation approaches have shown promise in improving outcomes for spinal cord injury patients.

Eligibility criteria

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.

Where this trial is running

Columbus, Ohio and 1 other locations

• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• University of British Columbia — Vancouver, Canada (Recruiting)

Study contacts

• Principal investigator: D. Michele Basso, EdD — Ohio State University
• Study coordinator: Michele Basso, EdD, PT

Conditions Spinal Cord Injuries; Healthy; Spinal Cord Injury; SCI; Biomarkers; MRI; Locomotor Training; Downhill