Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop — L300  

Poststroke/CVA Hemiparesis Clinical Trial

Official title: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop

Status Completed

Clinical Trial Summary

The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.

Clinical Trial Description

Approximately 176 subjects with stroke that have drop foot will be enrolled from approximately 10 different sites in the United States depending on the rate of enrollment. This clinical study is proposed to show that the FES delivered via the L300 improves gait function, stroke-specific quality of life, and safety for persons with stroke. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Gait Disorders, Neurologic
• Gait, Drop Foot
• Neurologic Ambulation Disorder
• Poststroke/CVA Hemiparesis
• Sensorimotor Gait Disorder

• NCT number: NCT01138995
• Study type: Interventional
• Source: Bioness Inc
• Status: Completed
• Phase: Phase 4
• Start date: May 2010
• Completion date: February 2013