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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant | Experimental | Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IST (Implanted Stimulator-Telemeter) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | Change from immediately after intervention and 1 year after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from immediately after intervention and 1 year after intervention |
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Phase I Inclusion Criteria
Phase I Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa M Lombardo, MPT | Contact | 216-791-3800 | 64909 | lisa.lombardo2@va.gov |
| Maura Malenchek, PTA | Contact | 216-791-3800 | 64989 | maura.malencheck@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ronald J Triolo, Ph.D. | Case Western Reserve University | Principal Investigator |
| Musa L Audu, Ph.D. | Louis Stokes Cleveland VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes Cleveland VA Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17946304 | Background | Dutta A, Kobetic R, Triolo RJ. Ambulation after incomplete spinal cord injury with electromyogram-triggered functional electrical stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:5408-11. doi: 10.1109/IEMBS.2006.259257. | |
| 15218941 | Background | Uhlir JP, Triolo RJ, Davis JA Jr, Bieri C. Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury. IEEE Trans Neural Syst Rehabil Eng. 2004 Jun;12(2):279-87. doi: 10.1109/TNSRE.2004.827224. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D020521 | Stroke |
| D010243 | Paralysis |
| D011782 | Quadriplegia |
| D010264 | Paraplegia |
| D009422 | Nervous System Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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|
| MetroHealth System | Recruiting | Cleveland | Ohio | 44109 | United States |
|
| 15077659 | Background | Bogie KM, Triolo RJ. Effects of regular use of neuromuscular electrical stimulation on tissue health. J Rehabil Res Dev. 2003 Nov-Dec;40(6):469-75. doi: 10.1682/jrrd.2003.11.0469. |
| 14582528 | Background | Agarwal S, Triolo RJ, Kobetic R, Miller M, Bieri C, Kukke S, Rohde L, Davis JA Jr. Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. J Rehabil Res Dev. 2003 May-Jun;40(3):241-52. |
| 11767968 | Background | Davis JA Jr, Triolo RJ, Uhlir J, Bieri C, Rohde L, Lissy D, Kukke S. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. 2001 Nov-Dec;38(6):609-17. |
| 17947042 | Result | Fisher LE, Miller ME, Nogan SJ, Davis JA, Anderson JS, Murray LM, Tyler DJ, Triolo RJ. Preliminary evaluation of a neural prosthesis for standing after spinal cord injury with four contact nerve-cuff electrodes for quadriceps stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:3592-5. doi: 10.1109/IEMBS.2006.260833. |
| 17873417 | Result | Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. doi: 10.1088/1741-2560/4/3/S05. Epub 2007 Aug 22. |
| 28899825 | Derived | Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9. |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |