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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
IST (Implanted Stimulator-Telemeter)
DevicePre-surgical exercise with surface electrical stimulation, surgery including electrode and IST- implanted pulse generator insertion, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: ImplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
Repeated measures of standing duration in minutes
Time frame
Change from immediately after intervention and 1 year after intervention2
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
Repeated measures of arm/leg loading measured in Kg
Time frame
Change from immediately after intervention and 1 year after intervention3
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
Repeated measures of walking distance in meters
Time frame
Change from immediately after intervention and 1 year after intervention4
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
Repeated measures of walking time in minutes
Time frame
Change from immediately after intervention and 1 year after interventionSecondary outcomes
1
Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge
Repeated measures of standing reach in cm, and transfer height in cm
Time frame
Change from immediately after intervention and 1 year after interventionSponsors and contacts
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Source ClinicalTrials.gov