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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

No Placebo-Only Group

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

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 more

Secondary 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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 1Eligibility criteria met