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Behavioural Intervention
Muscle Training + Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By D. Michele Basso, EdD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy controls: Adults 18-85 years old; no recent major musculoskeletal injury; no recent surgery.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Summary
This trial is testing a new rehabilitation treatment for people with spinal cord injuries, which includes checking for certain biomarkers to determine the best time to start the new training program. The 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. The goal is to improve trunk and leg movement, walking, and overall function.
Who is the study for?
This trial is for adults aged 18-85 with spinal cord injury (SCI) within 1-5 months post-injury, discharged from inpatient rehab, and without recent surgeries or major injuries. Healthy controls of the same age range can also join if they meet similar health criteria. Participants must not have conditions like active cancer or clotting disorders, be pregnant, or have cognitive issues preventing consent.
What is being tested?
The study tests a new rehabilitation treatment combining downhill treadmill training with electrical muscle stimulation against standard rehab alone. It aims to determine the optimal timing to start this program by analyzing biomarkers in blood and spinal fluid and assessing recovery of movement through MRI scans.
What are the potential side effects?
Potential side effects may include discomfort from electrical stimulation, muscle soreness due to eccentric training, risks associated with blood draws and lumbar punctures for biomarker analysis, and typical MRI-related concerns such as claustrophobia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18-85 years old, with no recent major injuries or surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in electromyography of eccentric acting muscles
Change from baseline in kinematics during weight acceptance: ankle acceleration
Change from baseline in kinematics during weight acceptance: ankle range of motion
+6 moreSecondary study objectives
Change from 12 weeks to 16 weeks in 10 Meter Walk Test
Change from 12 weeks to 16 weeks in 6 Minute Walk Test (6MWT)
Change from 12 weeks to 16 weeks in American Spinal Injury Association (ASIA) Impairment Scale (AIS)
+29 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: SCI No GoExperimental Treatment1 Intervention
Participants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months.
Group II: SCI GoExperimental Treatment1 Intervention
Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately.
Group III: SCI SOCActive Control1 Intervention
Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy.
Group IV: Healthy ControlActive Control1 Intervention
Healthy controls will provide biomarker and/or myelin (MRI) data
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,716 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,429 Total Patients Enrolled
University of Notre DameOTHER
33 Previous Clinical Trials
61,545 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My spinal cord injury is between my neck and upper abdomen.I have not had surgery recently.I haven't had any major injuries to my bones or muscles recently.I had a spinal cord injury between 1-5 months ago, am aged 18-85, and have been discharged from rehab.I do not have implanted devices unsuitable for MRI, neurological conditions, current cancer, clotting disorders, inflammatory conditions, am not pregnant, and can undergo procedures involving needles and confined spaces.I am between 18-85 years old, with no recent major injuries or surgeries.I have been discharged from inpatient rehab.I am between 18 and 85 years old.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: SCI SOC
- Group 2: SCI Go
- Group 3: SCI No Go
- Group 4: Healthy Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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