Stroke Clinical Trial
Official title:
Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008
The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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