Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

US Department of Veterans Affairs (VA)

Status: Terminated

Conditions: Stroke

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00864708

B3252-R

B3513R (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Arm 1

Experimental group

Description:

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

Treatment:

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