NCT01570816

Improving Ambulatory Community Access After Paralysis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Louis Stokes VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Partial Paralysis
• Spinal Cord Injury
• Tetraplegia
• Quadriplegia

Interventions

Type	Name	Description
DEVICE	IRS-8 (8 channel implanted receiver stimulator)	Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities

Timeline

• Start date: 2012-04-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2012-04-04
• Last updated: 2018-03-14

Locations

1 site across 1 country: United States