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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ post 6 weeks of training and 8 weeks after the end of training
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post 6 weeks of training and 8 weeks after the end of training
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
200 Previous Clinical Trials
17,085 Total Patients Enrolled
Ming Wu, PhD5.06 ReviewsPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
1 Previous Clinical Trials
36 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can move my legs enough to walk.I received a Botox injection in the last 6 months and am undergoing physical therapy.I have had multiple fractures or injuries to my legs.I have a metal implant in my spine.I have a brain injury or nerve damage in my legs.I can walk on a treadmill for over 20 minutes, with breaks and support if needed.I can walk more than 10 meters without or with knee-supporting orthotics.My spinal cord injury is between my neck and mid-back.I do not have open sores, infections, or severe heart/lung conditions.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: treadmill only
- Group 2: robotic training & stimulation
- Group 3: robotic training & sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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