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Improving Ambulatory Community Access After Paralysis

NCT01570816 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-03-14

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

IRS-8 (8 channel implanted receiver stimulator)

Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities

Sponsors & Collaborators

  • Louis Stokes VA Medical Center

    lead FED

Principal Investigators

  • Rudi Kobetic, MSBE · Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01570816 on ClinicalTrials.gov