New rehabilitation approach for walking recovery after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: michele.basso@osumc.edu
• Phone: 614-814-1404

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.