Evaluation of an Advanced Lower Extremity Neuroprostheses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
Qualifiers
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
Innervated and excitable lower extremity and trunk musculature
Adequate social support and stability
Willingness to comply with follow-up procedures
Disqualifiers
Non-English speaking
Females who are pregnant
Current pressure injuries that would be exacerbated by study activities
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
Trial design
Treatments tested in this trial
- IST (Implanted Stimulator-Telemeter)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov