Improving Ambulatory Community Access After Paralysis

March 12, 2018 updated by: Rudi Kobetic, Louis Stokes VA Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
        • Contact:
        • Principal Investigator:
          • Rudi Kobetic, MSBE
        • Sub-Investigator:
          • Gilles Pinault, M.D.
        • Sub-Investigator:
          • Stephen Selkirk, M.D., Ph.D.
        • Sub-Investigator:
          • Ronald J Triolo, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Device: IRS-8 (8 channel implanted receiver stimulator)
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities
Other Names:
  • Implanted pulse generator for ambulation
  • Implanted FES system for lower extremities
  • Implated FES system for ambulation
  • FES system for walking
  • Implanted neuroprosthesis for gait correction
  • Gait correction in partial paralysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without stimulation to determine if individuals are able to improve community ambulatory access with use of neuroprosthesis.
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without accelerometer triggered stepping to determine if individuals are able to adjust to environmental circumstances and situations encountered in community ambulation.
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Stokes VA Medical Center

Investigators

  • Principal Investigator: Rudi Kobetic, MSBE, Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (ESTIMATE)

April 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12004-H02
  • 1I01RX000528-01A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on IRS-8 (8 channel implanted receiver stimulator)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe