No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 75
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
10 (estimated)
Sponsor
Case Western Reserve University · Other
Who this trial is looking for
This trial is looking for adults with paralysis from conditions like stroke or spinal cord injuries. Participants will try a device implanted in the body to help with exercise, standing, and balance.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have paralysis that is not dependent on a ventilator.
I have muscles in my lower body and trunk that respond to stimulation.
I have social support and am stable in my living situation.
I am willing to attend follow-up appointments.
You may not be able to join if
I do not speak English.
I am currently pregnant.
I have pressure injuries that could get worse with activity.
I have severe stiffness or spasticity that prevents movement in my joints.
I have previously broken bones or have very low bone density.
I have balance problems or have fallen without warning.
I have untreated orthopedic issues that stop me from exercising.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.
Trial Locations
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Status
Eligibility Criteria
Phase I Inclusion Criteria
1. Skeletal maturity and ability to sign informed consent (\>18 years)
2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower lim…
Phase I Inclusion Criteria
1. Skeletal maturity and ability to sign informed consent (\>18 years)
2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
3. Innervated and excitable lower extremity and trunk musculature
4. Adequate social support and stability
5. Willingness to comply with follow-up procedures
Phase I Exclusion Criteria
1. Non-English speaking
2. Females who are pregnant
3. Current pressure injuries that would be exacerbated by study activities
4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
5. History of spontaneous fractures or other evidence of excessively low bone density
6. History of vestibular dysfunction, balance problems, or spontaneous falls
7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
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