Clinical trial NCT01570816: Improving Ambulatory Community Access After Paralysis
Official title: Improving Ambulatory Community Access After Paralysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Partial Paralysis
Spinal Cord Injury
Tetraplegia
Quadriplegia
Keywords: stroke
partial paralysis
gait correction
functional electrical stimulation
paraplegia
tetraplegia
spinal cord injury
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
First posted: 2012-04-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
timeFrame: up to 36 months
Secondary outcomes:
measure: 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
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
state: Ohio
Study officials:
affiliation: Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
name: Rudi Kobetic, MSBE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.