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Electrical Stimulation

Robotic & Electrical Stimulation for Spinal Cord Injury

N/A
Recruiting
Led By Ming Wu, PhD
Research Sponsored by Shirley Ryan AbilityLab
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 post 6 weeks of training and 8 weeks after the end of training
Awards & highlights

Study Summary

This trial studies if a combo of exercise & electricity can help improve walking & balance in people with SCI. One group gets the combo, one group get exercise & sham, one group just exercise.

Who is the study for?
This trial is for adults aged 18-65 with spinal cord injuries between C4-T10 who can walk on a treadmill for over 20 minutes and more than 10 meters without or with knee-high orthotics. They must be medically stable and not have severe diseases, recent fractures, Botox treatments within six months, ongoing physical therapy, or metal implants in the spine.Check my eligibility
What is being tested?
The study tests if pelvis perturbation training combined with electrical stimulation improves balance and walking in people with SCI. Participants are divided into three groups: one gets training plus real stimulation (tsDCS), another gets training plus fake stimulation (sham), and the last group only does treadmill exercises.See study design
What are the potential side effects?
Potential side effects may include discomfort from the electrical stimulation or skin irritation where electrodes are placed. Treadmill exercise might cause muscle soreness or fatigue. The exact side effects will vary among individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post 6 weeks of training and 8 weeks after the end of training
This trial's timeline: 3 weeks for screening, Varies for treatment, and post 6 weeks of training and 8 weeks after the end of training for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in overground gait speed from baseline
Secondary outcome measures
Changes in 6 minutes walking distance from baseline
Changes in balance (BBS score) from baseline
Changes in dynamic gait index from baseline

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: robotic training & stimulationExperimental Treatment3 Interventions
Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.
Group II: robotic training & shamActive Control2 Interventions
Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.
Group III: treadmill onlyPlacebo Group1 Intervention
Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
treadmill
2014
N/A
~220

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,858 Total Patients Enrolled
Ming Wu, PhD5.06 ReviewsPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Spinal Cord Electrical Stimulation (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT02991248 — N/A
Spinal Cord Injury Research Study Groups: treadmill only, robotic training & stimulation, robotic training & sham
Spinal Cord Injury Clinical Trial 2023: Spinal Cord Electrical Stimulation Highlights & Side Effects. Trial Name: NCT02991248 — N/A
Spinal Cord Electrical Stimulation (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02991248 — N/A

Frequently Asked Questions

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

Is the recruitment process for this experiment still underway?

"According to clinicaltrials.gov, this experiment is currently recruiting participants. It was first announced on November 1st 2018 and the most recent update was posted on November 2nd 2022."

Answered by AI

What is the highest possible participant count for this experiment?

"Affirmative, the details on clinicaltrials.gov indicate that this experiment is still seeking participants. Published in 2018 and last amended in 2022, it seeks 54 test subjects from one location."

Answered by AI

Is eligibility open to join this clinical investigation?

"This research is aiming to enroll 54 individuals, aged 18-65 and diagnosed with spinal cord injury. Additionally, these patients must have a SCI lesion between C4-T10; be able to ambulate without orthotics or with non-knee crossing prosthetics for more than 10 meters; possess active range of motion that allows them to perform ambulatory tasks; demonstrate the capability of walking on a treadmill for 20 minutes under partial body weight support if needed as well as short sitting/standing breaks."

Answered by AI

Is this research project including individuals aged over 30?

"To qualify for this study, participants must be within the ages of 18 to 65. For those outside these age requirements, there are 37 trials available for patients younger than 18 and 306 applicable studies for those over 65 years old."

Answered by AI
~5 spots leftby Oct 2024