Improving Ambulatory Community Access After Paralysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Louis Stokes VA Medical Center
Sponsor:
Information provided by (Responsible Party):
Rudi Kobetic, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier:
NCT01570816
First received: April 2, 2012
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Partial Paralysis
Tetraplegia
Quadriplegia
Device: IRS-8 (8 channel implanted receiver stimulator)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Ambulatory Community Access After Paralysis

Resource links provided by NLM:


Further study details as provided by Louis Stokes VA Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 6
Study Start Date: April 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570816

Contacts
Contact: Lisa M Lombardo, MPT 216-791-3800 ext 4909 llombardo@fescenter.org

Locations
United States, Ohio
Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lisa M Lombardo, MPT    216-791-3800 ext 4909    llombardo@fescenter.org   
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.         
Sponsors and Collaborators
Louis Stokes VA Medical Center
Investigators
Principal Investigator: Rudi Kobetic, MSBE Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Rudi Kobetic, Biomedical Engineer, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier: NCT01570816     History of Changes
Other Study ID Numbers: 12004-H02, 1I01RX000528-01A2
Study First Received: April 2, 2012
Last Updated: August 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Louis Stokes VA Medical Center:
spinal cord injury
partial paralysis
gait correction
functional electrical stimulation
paraplegia
tetraplegia

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Paralysis
Paresis
Muscle Weakness
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014