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.
Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system. Patients are followed at 6 and 12 months after discharge and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Pre-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.
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
RECRUITINGMetroHealth System
Cleveland, Ohio, United States
RECRUITINGDevice 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 intervention
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 intervention
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 intervention
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 intervention
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 intervention
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