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Powered Exoskeleton
Powered Exoskeleton for Spinal Cord Injury (EKSO Trial)
N/A
Waitlist Available
Led By Arun Jayaraman, 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 testing day 1 - 3 and follow up testing week 6 and week 12.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a device called Ekso to see if it is safe and effective for people with spinal cord injuries or similar neurological weaknesses. The device helps the person stand, walk, and turn, and sit down. The trial will test if the person using Ekso can safely balance and walk without losing balance, and if they improve in weight shift and other activities.
Who is the study for?
This trial is for adults aged 18-65 with spinal cord injury (SCI) levels C7-S1 or similar neurological weakness, who can fit into and tolerate the Ekso exoskeleton. They must stand for 30 minutes and have upper body strength to use a walker. Excluded are those with skin issues, cognitive impairments, extreme height/weight, joint contractures limiting movement, severe osteoporosis without physician approval.
What is being tested?
The EKSO Trial tests the safety and effectiveness of an Ekso powered exoskeleton in helping individuals with SCI walk again. It evaluates balance improvement while standing, ability to walk 10 meters safely, better weight shifting during movement as assessed by therapists, and user feedback on device training success.
What are the potential side effects?
Potential side effects may include discomfort from wearing the device, skin irritation at contact points with the exoskeleton, muscle fatigue due to physical activity or strain from balancing and walking efforts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1- 3 after the first trial of the ekso, follow up testing on week 6 and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1- 3 after the first trial of the ekso, follow up testing on week 6 and week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in 10 meter walk test from baseline in gait speed
Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake
Secondary study objectives
2 Minute Walk Test
Ratio of number of steps/walking time
Walk time to stand time ratio on a particular assistive device
Other study objectives
Psychosocial Impact of Assistive Device Scale (PIADS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ekso Safety and EfficacyExperimental Treatment1 Intervention
Observational study on the first time use of a robotic exoskeleton.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
17,985 Total Patients Enrolled
2 Trials studying Paralysis
83 Patients Enrolled for Paralysis
United States Department of DefenseFED
908 Previous Clinical Trials
333,640 Total Patients Enrolled
2 Trials studying Paralysis
59 Patients Enrolled for Paralysis
Arun Jayaraman, PhDPrincipal InvestigatorRIC/Northwestern
5 Previous Clinical Trials
215 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are shorter than 62 inches or taller than 74 inches.You weigh more than 220 pounds.You must be between 18 and 65 years old.You must be able to stand upright for at least 30 minutes without any problems.You have stiff joints that make it difficult to move normally with help from devices like crutches or walkers.You have a medical condition that prevents you from standing and walking normally, like a serious bone or muscle injury.You must have a spinal cord injury between the C7 and S1 vertebrae.You need to have enough strength in your upper body to use a walker and wear the exoskeleton.You have a different type of neurological weakness than spinal cord injury, but you meet all the other criteria to participate in the study.If you have a severe bone condition called osteoporosis, with a T score below -3, your doctor will decide if you can take part in the study.You have skin problems that would make it hard to wear the device.You need to be able to move your joints normally in order to walk properly.
Research Study Groups:
This trial has the following groups:- Group 1: Ekso Safety and Efficacy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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