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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

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.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,586 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,550 Total Patients Enrolled
University of Notre DameOTHER
33 Previous Clinical Trials
61,545 Total Patients Enrolled

Media Library

Downhill Eccentric Treadmill Training with Electrical Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05337982 — N/A
Spinal Cord Injury Research Study Groups: SCI SOC, SCI Go, SCI No Go, Healthy Control
Spinal Cord Injury Clinical Trial 2023: Downhill Eccentric Treadmill Training with Electrical Stimulation Highlights & Side Effects. Trial Name: NCT05337982 — N/A
Downhill Eccentric Treadmill Training with Electrical Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05337982 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in the current investigation?

"Indeed, clinicaltrials.gov data confirms that this experiment is currently seeking participants. The trial was first posted on August 25th 2022 and updated most recently on July 27th 2022. To complete the study 49 subjects need to be sourced from one selected centre of care."

Answered by AI

Does this trial encompass individuals aged 20 or older?

"Those wishing to enroll in this research must be between the ages of 18 and 85. There are 87 studies available for minors, while 672 trials have been established for geriatric patients."

Answered by AI

Are there currently vacancies for participants in this research?

"Data on clinicaltrials.gov implies that this medical trial is currently recruiting participants, having originated in August 2022 and then most recently edited nearly a month later."

Answered by AI

Is it feasible for me to join this research project?

"This medical study seeks to enrol 49 individuals that have suffered from a spinal cord injury, ranging in age from 18 to 85 years old. To be eligible for participation, patients must fit the following criteria: completed rehabilitation; an AIS rating of A-D at C1-T10 level of neurologic impairment; lack any recent musculoskeletal injuries and surgeries."

Answered by AI

What objectives are this research endeavor aiming to accomplish?

"The primary outcome of this clinical trial, which is to be evaluated over a 12-week period, will focus on the electromyography results of eccentric acting muscles. Secondary outcomes include changes in knee acceleration while walking on a treadmill from baseline at 12 and 16 weeks respectively; additionally, SCIM3 scores that indicate independence across self-care tasks (0-20), respiration/sphincter management (0-40) and mobility items 9-17 (also 0-40). Lastly, ankle acceleration during weight acceptance will also be monitored between week 12 and 16."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
The Ohio State University
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. The Ohio State University: < 48 hours
Average response time
  • < 2 Days
~11 spots leftby Dec 2024