RecruitingNAINTERVENTIONAL

Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

This study is exploring a new rehabilitation programme for people who have experienced a spinal cord injury and want to improve their walking. It involves walking gently downhill on a treadmill while mild electrical pulses help stimulate muscles that aren't working properly. Researchers will also take blood and spinal fluid samples to find out if certain natural body signals (biomarkers) can tell them exactly when is the best time to start this training – either straight away or after a few months. The hope is that this special training, given at the right time, will help people regain better movement in their legs and body, improve their walking, and overall daily activities, compared to standard care alone. Brain and spinal cord scans will also be done to see if the training changes these areas.

At a glance

Status

Recruiting

Phase

Sponsor

Ohio State University

Enrolment target

Start

17 May 2022

Estimated completion

31 Dec 2026

Spinal Cord Injuries Healthy

What is this study about?

Imagine you've had a spinal cord injury and are working hard to walk again. This study is testing a new and different approach to help you do just that. It's called "downhill eccentric treadmill training with electrical stimulation." This might sound complex, but it simply means walking gently downhill on a special treadmill. As you walk, mild electrical pulses are sent to your muscles that have been affected by your injury. These pulses help your muscles to work, allowing you to practice walking even if you don't have full control over them yet. This new training would be added to any regular rehabilitation you're already doing, not replace it.

One of the main goals of the study is to figure out the very best time to start this new training. To do this, researchers will look at special signals in your blood and spinal fluid, called 'biomarkers'. These biomarkers are like natural clues from your body that might show when your body is most ready to heal and respond to the training. By understanding these signals, the team hopes to know if it's better to start the training soon after your injury (around 3 months) or wait a little longer (around 6 months).

Participants in the study will have their movement, walking, and daily activities carefully checked before, during, and after the training. They'll also have special scans of their brain and spinal cord, called MRI scans, to see how the training affects these important areas. The overall aim is to see if this special downhill training, combined with electrical stimulation and given at the most ideal time, can lead to better recovery of movement and function compared to people who only receive standard rehabilitation.

Key takeaways

Tests a new training for walking after spinal cord injury.
Combines downhill treadmill walking with gentle electrical muscle stimulation.
Aims to find the best time to start this training using body's natural signals (biomarkers).
May involve blood tests, spinal fluid samples, and MRI scans.
Adds to existing rehabilitation, does not replace it.
Study participation can be up to 33 weeks for those with spinal cord injury.

Who may be eligible?

To join this study, people with a spinal cord injury usually need to be between 18 and 85 years old and have had their injury within the last 1 to 5 months. You also need to have been discharged from inpatient rehabilitation and your injury should be at a specific level (C1-T10) and severity range (AIS A-D). There are also some health conditions that would prevent you from taking part, such as certain other neurological problems, recent cancer, current blood clots, or if you are pregnant. If you have any skin wounds where the harness or electrical pads would go, you might not be able to join.

Healthy volunteers, who don't have a spinal cord injury, are also needed for comparison. They should be between 18 and 85 years old and generally healthy, meaning no serious recent injuries or surgeries. Like those with spinal cord injuries, healthy volunteers cannot be pregnant, have certain neurological conditions, active cancer, or some inflammatory conditions like arthritis. Also, if you have certain metal implants in your body that could be affected by MRI scans, you might not be able to participate in that part of the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Did your spinal cord injury happen 1 to 5 months ago?
Have you been discharged from inpatient rehabilitation?
Do you have an American Spinal Injury Association (ASIA) Impairment Scale (AIS) score between A and D?
Do you have any metal implants that might be a problem for MRI scans or electrical stimulation?

Answer every question to see your result.

What does participation involve?

If you have a spinal cord injury and join this study, your journey could last between 16 and 33 weeks, depending on which group you're in. This includes several assessment visits. If you're in one of the training groups, you'll have 12 weeks of special downhill treadmill training sessions, three times a week. These sessions will involve walking on a treadmill with a slight downhill slope, with gentle electrical stimulation to your muscles and harness support if needed. You'll also have blood and spinal fluid samples taken, and MRI scans of your brain and spinal cord.

All participants with spinal cord injury will have assessments before the study starts, right after the main part of the study, and then again about four weeks later. These assessments will look at your movements, walking, and general function. If you're a healthy control participant, your involvement will be much shorter, usually just 1 or 2 visits for assessments and possibly MRI scans.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. You might not directly benefit from this study, but the information gathered could help doctors understand how to better treat spinal cord injuries in the future. The downhill treadmill training with electrical stimulation is a new approach, and while it's hoped to improve movement, there's no guarantee it will work for everyone. Potential risks specific to this study include discomfort or a small risk during blood collection, and a procedure called a lumbar puncture for spinal fluid collection, which can cause a headache or mild pain, though experienced staff will perform it carefully. MRI scans are generally safe but require you to lie still in an enclosed space. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

The Ohio State University
Verified postcode
Columbus, United States· Recruiting
University of British Columbia
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'downhill eccentric treadmill training'?

It's a special type of exercise where you walk on a treadmill going slightly downhill, which helps to train your muscles in a particular way that might be good for recovery.

What is 'electrical stimulation'?

This involves mild electrical pulses sent to your muscles. It helps them to contract and work, allowing you to practice movements even if you don't have full control.

Why do you need blood and spinal fluid samples?

Researchers want to look for natural signals (biomarkers) in these fluids. These signals might tell them the best time for your body to start the new training programme for the best results.

Will this training replace my current rehabilitation?

No, this special training will be in addition to any other rehabilitation you're already doing. It's meant to be an extra help, not a replacement.

What is a 'lumbar puncture'?

This is a procedure where a small sample of fluid from around your spinal cord is taken for testing. It's done by experienced medical staff and is usually quite quick.

How to find out more

Michele Basso, EdD, PT

michele.basso@osumc.edu 614-814-1404 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.