Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

NCT ID: NCT00864708

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-04-30

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Fully Implanted FES system to assist patient with gait component practice

Interventions

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

Fully Implanted FES system to assist patient with gait component practice

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred E. Mann Foundation for Scientific Research

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janis Daly, PhD MS

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center-Cleveland

Locations

VA Medical Center, Cleveland

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

B3513R

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

B3252-R

Identifier Type: -

Identifier Source: org_study_id