New Training Program for Spinal Cord Injury Recovery
Eccentric Muscle Training, Stimulation, and Biomarkers in SCI
Recruiting
N/AInterventional Study
Spinal Cord InjuriesHealthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
49 (estimated)
Sponsor
Ohio State University · Other
Who this trial is looking for
This trial is looking for people with spinal cord injuries or healthy adults to test a new rehabilitation program aimed at improving walking. Participants will undergo a training program that includes walking on a treadmill while muscles are stimulated, along with tests of blood and spinal fluid.
Are You a Good Fit for This Trial?
Rules you outClotting disordersInflammatory conditions like arthritis
You may be able to join if
I have a spinal cord injury within 1-5 months of injury.
I am 18-85 years old.
I have been discharged from inpatient rehabilitation.
I have a neurological level from C1 to T10.
I am a healthy adult aged 18-85 years old.
I have no recent major musculoskeletal injury.
I have no recent surgery.
You may not be able to join if
I have used botox in the past 3 months.
I have another neurological condition like brain injury or stroke.
I currently have cancer.
I have deep vein thrombosis or take anti-coagulation therapy.
I am pregnant.
I depend on a ventilator.
I have cognitive conditions that prevent me from giving informed consent.
I have skin wounds that interfere with necessary training equipment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
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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 CRITE…
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.
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