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Locomotor training for Spinal Cord Injury

N/A
Waitlist Available
Led By Emily Fox, PT, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 4
Awards & highlights

Study Summary

This study is evaluating whether a type of electrical stimulation may help improve walking ability for individuals with incomplete spinal cord injury.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 4 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 in 10-Meter Walk Test (Interventional)
Change in Electromyogram (EMG; Immediate)
Secondary outcome measures
Change in 6-Minute Walk Test (Interventional)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Interventional effects: Higher dosageExperimental Treatment2 Interventions
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Group II: Immediate effectsExperimental Treatment1 Intervention
All participants will complete 2 sessions of walking with tsDCS separated by at least 72 hours. The only difference between sessions will be the dosage of stimulation (higher or lower dosage tsDCS using the Soterix Medical tsDCS stimulator). During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.
Group III: Interventional effects: Lower dosageActive Control2 Interventions
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,866 Total Patients Enrolled
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,657 Total Patients Enrolled
Brooks RehabilitationOTHER
13 Previous Clinical Trials
1,743 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Stimulation to Enhance Walking Post-SCI
2019. "Stimulation to Enhance Walking Post-SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03702842.
~2 spots leftby Apr 2025
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