Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

This study has been completed.

Sponsor:

Collaborator:

The Alfred E. Mann Foundation for Scientific Research

Information provided by:

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00864708

First received: March 17, 2009

Last updated: October 5, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 17, 2009

Last Updated Date

October 5, 2010

Start Date ^ICMJE

December 2008

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Kinematic swing phase gait components and walking endurance [ Time Frame: months 1, 3, 6 and at follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00864708 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Official Title ^ICMJE

Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Brief Summary

The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.

Detailed Description

Background and Purpose: Conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. Functional neuromuscular stimulation (FNS) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. Gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. The purpose of the proposed work is to test the radio frequency-controlled (RF) Microstimulator (RFM) Gait System regarding system performance and subject response to treatment.

Methods: This is a feasibility study in which up to four subjects will receive the (RFM) Gait System. Up to ten RFMs will be placed for a given subject. An RFM ankle muscle system will be used to train ankle gait components. A separate RFM system will be used to train knee gait components. Subjects will be treated for 6 months, four sessions/wk. Primary outcome measures for the RFM Gait System will be: kinematic swing phase gait components and walking endurance. Secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. Data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. The results of the RFM ankle system have the potential to provide a new technology for ankle muscle gait components.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Fully Implanted FES system to assist patient with gait component practice

Study Arm (s)

Experimental: 1

radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Intervention: Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Sufficient endurance to participate in rehabilitation sessions.
Medically Stable
Age >21 years.
Inability to perform normal ankle coordinated gait components.
Participants should be able to walk and keep balance without physical assistance from another person

Exclusion Criteria:

Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
Lower motor neuron damage or radiculopathy
Allergy or contraindication to anesthesia, Versed, (or comparable substitute.
Active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device.
Pregnancy

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00864708

Other Study ID Numbers ^ICMJE

B3252R, B3513R

Has Data Monitoring Committee

Yes

Responsible Party

Daly, Janis - Principal Investigator, Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

The Alfred E. Mann Foundation for Scientific Research

Investigators ^ICMJE

Principal Investigator:

Janis Daly, PhD MS

VA Medical Center, Cleveland

Information Provided By

Department of Veterans Affairs

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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