Back to results

Improving Ambulatory Community Access After Paralysis

Primary Purpose

Stroke, Partial Paralysis, Spinal Cord Injury

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

IRS-8 (8 channel implanted receiver stimulator)

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, partial paralysis, gait correction, functional electrical stimulation, paraplegia, tetraplegia, spinal cord injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Louis Stokes Cleveland Dept. of Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis

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

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.

Full Information

NCT ID

NCT01570816

First Posted

April 2, 2012

Last Updated

March 12, 2018

Sponsor

Louis Stokes VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01570816

Brief Title

Improving Ambulatory Community Access After Paralysis

Official Title

Improving Ambulatory Community Access After Paralysis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Louis Stokes VA Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

stroke, partial paralysis, gait correction, functional electrical stimulation, paraplegia, tetraplegia, spinal cord injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

IRS-8 (8 channel implanted receiver stimulator)

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis

Description

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Description

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa M Lombardo, MPT

Phone

216-791-3800

Ext

4909

llombardo@fescenter.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudi Kobetic, MSBE

Organizational Affiliation

Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa M Lombardo, MPT

Phone

216-791-3800

Ext

4909

llombardo@fescenter.org

First Name & Middle Initial & Last Name & Degree

Rudi Kobetic, MSBE

First Name & Middle Initial & Last Name & Degree

Gilles Pinault, M.D.

First Name & Middle Initial & Last Name & Degree

Stephen Selkirk, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Ronald J Triolo, Ph.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

20437323

Citation

Bailey SN, Hardin EC, Kobetic R, Boggs LM, Pinault G, Triolo RJ. Neurotherapeutic and neuroprosthetic effects of implanted functional electrical stimulation for ambulation after incomplete spinal cord injury. J Rehabil Res Dev. 2010;47(1):7-16. doi: 10.1682/jrrd.2009.03.0034.

Results Reference

background

PubMed Identifier

18247230

Citation

Hardin E, Kobetic R, Murray L, Corado-Ahmed M, Pinault G, Sakai J, Bailey SN, Ho C, Triolo RJ. Walking after incomplete spinal cord injury using an implanted FES system: a case report. J Rehabil Res Dev. 2007;44(3):333-46. doi: 10.1682/jrrd.2007.03.0333.

Results Reference

background

PubMed Identifier

28899825

Citation

Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.

Results Reference

derived

Links:

URL

http://fescenter.org

Description

Cleveland FES center website

Learn more about this trial

Improving Ambulatory Community Access After Paralysis

We'll reach out to this number within 24 hrs