Overview

This trial is active, not recruiting.

Conditions spinal cord injury, partial paralysis, tetraplegia, quadriplegia
Treatment irs-8 (8 channel implanted receiver stimulator)
Phase phase 1
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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) Implanted pulse generator for ambulation
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities

Primary Outcomes

Measure
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

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
time frame: up to 36 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Louis Stokes VA Medical Center.