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Improving Ambulatory Community Access After Paralysis

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ClinicalTrials.gov Identifier: NCT01570816
Recruitment Status : Recruiting
First Posted : April 4, 2012
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Rudi Kobetic, Louis Stokes VA Medical Center

Brief 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.

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

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  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Ambulatory Community Access After Paralysis
Study Start Date : April 2012
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Paralysis
Spinal Cord Injuries
Quadriplegia
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