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Treadmill training combined with muscle and spinal cord stimulation for Spinal Cord Injury (SCI-ES-WALK Trial)

N/A

Recruiting

Led By Kristine Cowley

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has difficulty with trunk and/or lower limb function

Has non-progressive etiology of spinal injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-training (on week 1) and within one week from end of training (on week 6)

Awards & highlights

SCI-ES-WALK Trial Summary

This trial aims to study the effects of non-invasive electrical stimulation on the spinal cord of individuals with spinal cord injuries to improve motor function in the trunk and lower limbs. The study will involve combining electrical

Who is the study for?

This trial is for individuals with spinal cord injuries or diseases, aiming to improve their motor functions. Participants should be able to undergo non-invasive electrical stimulation and participate in treadmill walking exercises.Check my eligibility

What is being tested?

The study tests the combination of non-invasive lumbar spinal cord electrical stimulation (ts-ES) with treadmill walking and peripheral neural stimulation on improving motor function in people with spinal cord injury.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, muscle fatigue from exercise, and skin irritation due to electrode placement.

SCI-ES-WALK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have trouble moving my body or legs.

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My spinal injury is not getting worse.

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I am between 20 and 65 years old.

SCI-ES-WALK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-training (on week 1) and within one week from end of training (on week 6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-training (on week 1) and within one week from end of training (on week 6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-training (on week 1) and within one week from end of training (on week 6) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Electromyography (EMG) of ankle extensor muscles

Metabolic function testing

Neurophysiological markers or stepping

Secondary outcome measures

6 Min Walk Test

Autonomic scores

Rate or Perceived Exertion (RPE) of Submaximal VO2 testing

+1 more

SCI-ES-WALK Trial Design

1Treatment groups

Experimental Treatment

Group I: Treadmill training combined with muscle and spinal cord stimulationExperimental Treatment3 Interventions

Locomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,471 Total Patients Enrolled

Kristine CowleyPrincipal InvestigatorUniversity of Manitoba

Katinka StecinaPrincipal InvestigatorUniversity of Manitoba

Frequently Asked Questions

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

What is the current participation count in this clinical trial?

"Indeed, details on clinicaltrials.gov specify that this medical trial is actively in search of suitable participants. The initial posting date was 15th June 2023, with the most recent revision occurring on 14th February 2024. This research endeavor aims to enroll a total of 10 patients from a single designated site."

Answered by AI

Which group of individuals would be the most suitable candidates to participate in this clinical study?

"Individuals aged between 20 and 65 with spinal cord pathology are sought for this research project, which aims to enlist a cohort of 10 participants."

Answered by AI

Are patients currently able to enroll in this ongoing clinical trial?

"Indeed, information from clinicaltrials.gov affirms the ongoing recruitment of participants for this trial. The trial was first posted on June 15th, 2023 and last updated on February 14th, 2024. It aims to enroll 10 patients at a single site."

Answered by AI

Is the clinical trial open to individuals above the age of 60 years?

"To be considered for participation in this study, individuals must be between 20 and 65 years of age."

Answered by AI

What are the objectives of this particular research endeavor?

"The primary objective of this clinical trial is to perform electromyography (EMG) on the ankle extensor muscles, with evaluations scheduled for week 1 and approximately one week post-training at week 6. Secondary goals encompass assessing SCIM-Spinal cord Independence Measure- Mobility scores as per Rick Hansen Institute guidelines; gauging Rate or Perceived Exertion (RPE) during Submaximal VO2 testing using the Borg scale range of 6-20; and conducting the 6-Minute Walk Test to measure distance covered in a controlled setting, ensuring safety measures are observed throughout."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

Katinka Stecina 2023. "Non-invasive Spinal Cord Stimulation After Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06260735.

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