Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2012-04-30
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
IRS-8 (8 channel implanted receiver stimulator)
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities
Interventions
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IRS-8 (8 channel implanted receiver stimulator)
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* weak hip flexors and extensors or excessive tone
* weak ankle dorsiflexors (muscles bringing the foot up)
* weak plantar flexors (ankle muscles for push-off)
* foot drop that is causing "dragging" or "catching" toes during walking
* swinging the leg sideways or hiking the hip to clear affected leg during stepping
* endurance to walk at least 10 ft with minimal assistance
* hip extension range to neutral
* hip flexion range greater or equal to 90 degrees
* ankle range to neutral
* sufficient upper extremity function to use a walking aid
* muscles respond to electrical stimulation
Exclusion Criteria
* demand pacemaker
* pregnancy
* Parkinson's disease
* traumatic brain injury
* autoimmune deficiency
* uncontrolled diabetes
* significant edema of the affected limb
* active pressure ulcers or open wounds
* sepsis or an active infection
* severe osteoporosis
* uncontrolled seizures
* moderate depression
18 Years
75 Years
ALL
No
Sponsors
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Louis Stokes VA Medical Center
FED
Responsible Party
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Rudi Kobetic
Biomedical Engineer
Principal Investigators
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Rudi Kobetic, MSBE
Role: PRINCIPAL_INVESTIGATOR
Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
Locations
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Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Bailey SN, Hardin EC, Kobetic R, Boggs LM, Pinault G, Triolo RJ. Neurotherapeutic and neuroprosthetic effects of implanted functional electrical stimulation for ambulation after incomplete spinal cord injury. J Rehabil Res Dev. 2010;47(1):7-16. doi: 10.1682/jrrd.2009.03.0034.
Hardin E, Kobetic R, Murray L, Corado-Ahmed M, Pinault G, Sakai J, Bailey SN, Ho C, Triolo RJ. Walking after incomplete spinal cord injury using an implanted FES system: a case report. J Rehabil Res Dev. 2007;44(3):333-46. doi: 10.1682/jrrd.2007.03.0333.
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.
Related Links
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Cleveland FES center website
Other Identifiers
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12004-H02
Identifier Type: -
Identifier Source: org_study_id
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