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Clinical Trial Summary

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


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT00864708
Study type Interventional
Source VA Office of Research and Development
Contact
Status Terminated
Phase N/A
Start date December 2008
Completion date April 2010

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