NCT01138995

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Bioness Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 functional electrical stimulation (FES) delivered via the Ness L300 improves gait function, stroke-specific quality of life, and safety for persons with stroke.

Conditions

• Sensorimotor Gait Disorder
• Neurologic Ambulation Disorder
• Gait, Drop Foot
• Poststroke Hemiparesis
• Post-Cerebrovascular Accident (CVA) Hemiparesis

Interventions

Type	Name	Description
DEVICE	Ness L300	The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
DEVICE	Ankle-foot orthosis	The Control Group will walk with a "usual" ankle-foot orthosis (AFO).

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2010-06-08
• Last updated: 2016-04-28
• Results posted: 2016-04-28

Locations

11 sites across 1 country: United States