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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#07101-H36 | Other Identifier | Case Western Reserve University |
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The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuroprosthesis | 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 |
|---|---|---|---|---|
| IRS-8 (8-Channel implanted stimulator-telemeter) | Device | Surgical implantation of the 8-channel neuroprosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. | Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility. | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Design a simple position controller | The position controller will be developed to keep the trunk posture at a neutral seated position while allowing movement to lean forward, backward, or side-to-side. Testing will be carried out with an automated pull system applied to the trunk which pulls the body in various ways (side-to-side, forward, backward) | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa M Lombardo, MPT | Contact | (216) 791-3800 | 4909 | Lisa.Lombardo2@va.gov |
| Emily C Johnson, BA | Contact | (216) 791-3800 | 64904 | emily.johnson17@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ronald Triolo, PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Recruiting | Cleveland | Ohio | 44106-1702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19236990 | Background | Triolo RJ, Boggs L, Miller ME, Nemunaitis G, Nagy J, Bailey SN. Implanted electrical stimulation of the trunk for seated postural stability and function after cervical spinal cord injury: a single case study. Arch Phys Med Rehabil. 2009 Feb;90(2):340-7. doi: 10.1016/j.apmr.2008.07.029. | |
| 15077659 | Background |
| Label | URL |
|---|---|
| Cleveland FES center website | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010243 | Paralysis |
| D011782 | Quadriplegia |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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. |
| 32795162 | Derived | Foglyano KM, Lombardo LM, Schnellenberger JR, Triolo RJ. Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion. J Spinal Cord Med. 2022 Mar;45(2):204-213. doi: 10.1080/10790268.2020.1800278. Epub 2020 Aug 14. |
| 29530053 | Derived | Armstrong KL, Lombardo LM, Foglyano KM, Audu ML, Triolo RJ. Automatic application of neural stimulation during wheelchair propulsion after SCI enhances recovery of upright sitting from destabilizing events. J Neuroeng Rehabil. 2018 Mar 12;15(1):17. doi: 10.1186/s12984-018-0362-2. |
| 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. |
| 23542776 | Derived | Wu GA, Lombardo L, Triolo RJ, Bogie KM. The effects of combined trunk and gluteal neuromuscular electrical stimulation on posture and tissue health in spinal cord injury. PM R. 2013 Aug;5(8):688-96. doi: 10.1016/j.pmrj.2013.03.025. Epub 2013 Mar 28. |
| 23500182 | Derived | Triolo RJ, Bailey SN, Miller ME, Lombardo LM, Audu ML. Effects of stimulating hip and trunk muscles on seated stability, posture, and reach after spinal cord injury. Arch Phys Med Rehabil. 2013 Sep;94(9):1766-75. doi: 10.1016/j.apmr.2013.02.023. Epub 2013 Mar 13. |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |