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Exoskeleton and Spinal Cord Stimulation for Spinal Cord Injury

This study is looking at how combining two treatments, Exoskeleton-Assisted Walking (EAW) and Transcutaneous Lumbosacral Stimulation (TLS), helps people with spinal cord injuries (SCI) improve their walking. EAW uses a robotic device to help you walk. TLS is a type of electrical stimulation applied to your lower back. The study wants to see if EAW with TLS works better than EAW alone. They will measure walking improvements using tests like the 6-minute walk test and 10-meter walk test. You may be able to join if you are 18-65 years old, have an SCI for more than 6 years, and have some movement in your legs. The study aims to enroll 24 participants, but the current recruitment status is unclear.

Study design
This is an interventional study that will randomly assign 24 participants with incomplete spinal cord injury to one of two groups: EAW+TLS or EAW alone.
What's involved
Participants will have 80 training sessions over 28 weeks, three times a week. Each session involves 60 minutes of robotic intervention and 15 minutes of overground training.
Compensation
Not stated in the trial record.
Follow-up
Walking measurements will be taken during the 28-week training intervention after 20, 40, 60, and 80 sessions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03096197

Exoskeleton and Spinal Cord Stimulation for SCI

Recruiting
NAAges 18–65InterventionalSupportive care
Kessler Foundation
~24 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:Exoskeleton-Assisted WalkingTranscutaneous Lumbosacral Stimulation (TLS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage change 6-minute walk test (6MWT)
Measured over 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.
+1 more outcome measured

Conditions

Spinal Cord Injury
Ambulation Difficulty
Muscle Spasticity

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Gail F. Forrest, PhD · PRINCIPAL_INVESTIGATOR · Kessler Foundation

Who to contact

Gail F Forrest, PhD
[email protected]
973-324-3518 · ext. 3518
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

be a non-walker with an SCI greater than 6 years post injury;
have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam;
be between the ages of 18-65 years old;
have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10;
be wheelchair reliant 100% of the time;
have knee bone mineral density great than .5755gm/cm2 as determined by study staff;

Exclusion

have a history of broken or fractured bones.
have a history of bone trauma or bone disease.

What this trial measures

  • Percentage change 6-minute walk test (6MWT)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.

    Participants undergoing EAW+TLS intervention will walk significantly further than those receiving EAW alone.

  • Percentage change 10 meter walk test (10MWT)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.

    Participants undergoing EAW+TLS intervention will walk significantly faster than those receiving EAW alone training.