Improving Ambulatory Community Access After Paralysis
This trial is active, not recruiting.
|Conditions||spinal cord injury, partial paralysis, tetraplegia, quadriplegia|
|Treatment||irs-8 (8 channel implanted receiver stimulator)|
|Sponsor||Louis Stokes VA Medical Center|
|Start date||April 2012|
|End date||July 2017|
|Trial size||6 participants|
|Trial identifier||NCT01570816, 12004-H02, 1I01RX000528-01A2|
The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
time frame: up to 36 months
Feasibility of initiating a step with a trigger from an accelerometer incorporated in the external control unit to adjust to environmental circumstances and situations encountered in community ambulation
time frame: up to 36 months
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - problems walking because of paralysis for more than 6 months - 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: - cardiac arrythmias - 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
|Official title||Improving Ambulatory Community Access After Paralysis|
|Principal investigator||Rudi Kobetic, MSBE|
|Description||In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.|
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