RecruitingNot ApplicableNCT05337982

Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

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

Sponsor

Ohio State University

Enrollment

49 participants

Start Date

May 17, 2022

Study Type

INTERVENTIONAL

Conditions

Healthy Spinal Cord Injuries

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria8

SCI participants WITHIN 1-5 MONTHS OF THEIR INJURY:
Discharged from inpatient rehabilitation;
AIS A-D at neurologic level C1-T10;
-85 years old.
Healthy controls:
Adults 18-85 years old;
no recent major musculoskeletal injury;
no recent surgery.

Exclusion Criteria20

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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Interventions

OTHERDownhill 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.