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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
Must not have
Have a history of bone trauma or bone disease
Have a history of broken or fractured bones
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

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.
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.
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 below
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My spinal cord injury is between my neck and mid-back.
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I use a wheelchair all the time.
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I am between 21 and 58 years old.
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I have been unable to walk for over 6 years due to a spinal cord injury.
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My leg strength score is 16 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had bone disease or injury in the past.
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I have had broken bones in the past.

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage change 10 meter walk test (10MWT)
Percentage change 6-minute walk test (6MWT)
Secondary study objectives
Absolute change in the International Standards Examination
Percentage change in scores on Berg Balance scale (BERG)
Other study objectives
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
178 Previous Clinical Trials
10,964 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

Exoskeleton-Assisted Walking Clinical Trial Eligibility Overview. Trial Name: NCT03096197 — N/A
Muscle Spasms Research Study Groups: EAW + TLS, EAW without TLS
Muscle Spasms Clinical Trial 2023: Exoskeleton-Assisted Walking Highlights & Side Effects. Trial Name: NCT03096197 — N/A
Exoskeleton-Assisted Walking 2023 Treatment Timeline for Medical Study. Trial Name: NCT03096197 — N/A
~3 spots leftby Sep 2025
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