Your session is about to expire
← Back to Search
Exoskeleton + Spinal Cord Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Gail F. Forrest, PhD
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a spinal cord injury at a neurological level of injury as determined by study staff between C6-T-10
Be wheelchair reliant 100% of the time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements will be performed during the 28 weeks of training intervention after baseline. training intervention is 28 weeks, 80 sessions total. measurements will be performed after 20, 40, 60 and 80 sessions.
Awards & highlights
Study Summary
This trial will study how a nerve stimulation device combined with an exoskeleton affects the ability to walk after an injury.
Who is the study for?
This trial is for adults aged 21-58 who are wheelchair reliant due to a spinal cord injury (SCI) that occurred over 6 years ago. Participants must be between 62 and 74 inches tall, have some lower limb movement, and no history of bone fractures or diseases.Check my eligibility
What is being tested?
The study is testing if using transcutaneous lumbosacral stimulation (TLS) while walking with an exoskeleton helps improve walking ability in people with SCI compared to just using the exoskeleton alone.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the device, muscle fatigue, discomfort during stimulation, and possible falls or injuries related to use of the exoskeleton.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury is between my neck and mid-back.
Select...
I use a wheelchair all the time.
Select...
I am between 21 and 58 years old.
Select...
I have been unable to walk for over 6 years due to a spinal cord injury.
Select...
My leg strength score is 16 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and immediately post intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and immediately post intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage change 10 meter walk test (10MWT)
Percentage change 6-minute walk test (6MWT)
Secondary outcome measures
Absolute change in the International Standards Examination
Percentage change in scores on Berg Balance scale (BERG)
Other outcome measures
percent change in ariel mineral bone density.
percent change in bone strength and bone stiffness.
percent change in volume metric and bone mineral density.
Trial Design
2Treatment groups
Experimental Treatment
Group I: EAW without TLSExperimental Treatment1 Intervention
EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .
Group II: EAW + TLSExperimental Treatment2 Interventions
The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).
Find a Location
Who is running the clinical trial?
Kessler FoundationLead Sponsor
174 Previous Clinical Trials
10,714 Total Patients Enrolled
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,141 Total Patients Enrolled
Gail F. Forrest, PhDPrincipal InvestigatorKessler Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had bone disease or injury in the past.I have had broken bones in the past.My spinal cord injury is between my neck and mid-back.I use a wheelchair all the time.I am between 21 and 58 years old.I have been unable to walk for over 6 years due to a spinal cord injury.Your height is between 5 feet 2 inches and 6 feet 2 inches.My leg strength score is 16 or higher.Your knee bone strength is greater than .5755gm/cm2 as determined by the study staff.
Research Study Groups:
This trial has the following groups:- Group 1: EAW + TLS
- Group 2: EAW without TLS
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the prerequisites for participants in this clinical trial?
"This clinical trial has 24 vacancies and the criteria for admission is a diagnosis of muscle spasms, along with an age range between 21 to 58."
Answered by AI
Is this research endeavor seeking out individuals aged 50 and above as participants?
"The protocol of this medical experiment requires that candidates are under 58 years of age and older than 21."
Answered by AI
Is this investigation in need of more participants?
"Per the clinicaltrials.gov website, this research endeavour is not presently enrolling patients; it was first announced on March 30th 2017 and last updated on August 18th 2017. At present time, there are 475 other trials actively recruiting volunteers."
Answered by AI
Recent research and studies
Share this study with friends
Copy Link
Messenger