Study 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.
Eligible Conditions
- Spinal Cord Injury
- Healthy Subjects
Treatment Effectiveness
Effectiveness Progress
Study Objectives
9 Primary · 32 Secondary · Reporting Duration: 16 weeks
12 weeks
Change from baseline in 10 Meter Walk Test
Change from baseline in 6 Minute Walk Test (6MWT)
Change from baseline in ASIA Impairment Scale (AIS)
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) scale
Change from baseline in Numeric Pain Rating Scale (NPRS)
Change from baseline in Spinal Cord Independence Measure III (SCIM3) score
Change from baseline in Strength Testing
Change from baseline in electromyography of eccentric acting muscles
Change from baseline in electromyography of eccentric acting muscles at 12 weeks
Change from baseline in kinematics during weight acceptance: ankle acceleration
Change from baseline in kinematics during weight acceptance: ankle range of motion
Change from baseline in kinematics during weight acceptance: hip acceleration
Change from baseline in kinematics during weight acceptance: hip range of motion
Change from baseline in kinematics during weight acceptance: knee acceleration
Change from baseline in kinematics during weight acceptance: knee range of motion
Change from baseline in kinetics during weight acceptance
Change from baseline in myelination in brain and spinal cord measured by Magnetic Resonance Imaging (MRI)
Change from baseline on Autonomic Standards Assessment Form
Change from baseline on Neuromuscular Recovery Scale (NRS) score
16 weeks
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)
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
Change from 12 weeks to 16 weeks in Neuropathic Pain Symptom Inventory (NPSI) scale
Change from 12 weeks to 16 weeks in Numeric Pain Rating Scale (NPRS)
Change from 12 weeks to 16 weeks in Spinal Cord Independence Measure III (SCIM3) score
Change from 12 weeks to 16 weeks in Strength Testing
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle acceleration
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle range of motion
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip acceleration
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip range of motion
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee acceleration
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee range of motion
Change from 12 weeks to 16 weeks in kinetics during weight acceptance
Change from 12 weeks to 16 weeks on Autonomic Standards Assessment Form
Change from 12 weeks to 16 weeks on Neuromuscular Recovery Scale (NRS) score
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
SCI SOC
1 of 4
Healthy Control
1 of 4
SCI No Go
1 of 4
SCI Go
1 of 4
Active Control
Experimental Treatment
49 Total Participants · 4 Treatment Groups
Primary Treatment: Downhill Eccentric Treadmill Training with Electrical Stimulation · No Placebo Group · N/A
SCI No Go
Other
Experimental Group · 1 Intervention: Downhill Eccentric Treadmill Training with Electrical Stimulation · Intervention Types: OtherSCI Go
Other
Experimental Group · 1 Intervention: Downhill Eccentric Treadmill Training with Electrical Stimulation · Intervention Types: OtherSCI SOCNoIntervention Group · 1 Intervention: SCI SOC · Intervention Types:
Healthy ControlNoIntervention Group · 1 Intervention: Healthy Control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
Who is running the clinical trial?
University of British ColumbiaOTHER
1,328 Previous Clinical Trials
1,534,638 Total Patients Enrolled
Ohio State UniversityLead Sponsor
716 Previous Clinical Trials
464,491 Total Patients Enrolled
United States Department of DefenseFED
779 Previous Clinical Trials
202,370 Total Patients Enrolled
University of Notre DameOTHER
31 Previous Clinical Trials
57,846 Total Patients Enrolled
D. Michele Basso, EdDPrincipal InvestigatorOhio State University
Eligibility Criteria
Age 18 - 85 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been discharged from inpatient rehabilitation.
You have a level C1-T10 neurological deficit.
Unbiased ResultsWe believe in providing patients with all the options.
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Conditions
Cancer Related
Treatments