Evaluation of the Safety and Performance of the NESS L300 Plus System — L300Plus  

Foot Drop Clinical Trial

Official title: Evaluation of the Safety and Performance of the NESS L300 Plus System

Status Completed

Clinical Trial Summary

The study is designed to evaluate the safety and efficacy of using the L300 Plus as a neuroprosthesis device for walking in patients following an UMN injury or disease. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study.

Clinical Trial Description

This is a prospective, one-center, single group, repeated measures, non inferiority study. Forty-five (45) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease will be evaluated for this study. Each subject will be in the study for six weeks. Clinical benefits will be measured through an assessment of the gait performance. In particular it will test the hypothesis that the NESS L300 Plus System which involves foot drop correction with thigh muscles activation, may achieve walking enhancements not inferior to those gained from using a system that only corrects foot drop (i.e. NESS L300). ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Drop
• Muscle Weakness
• Paresis
• Thigh Muscles Weakness (Hamstrings or Quadriceps)
• Upper Motor Neuron Injury or Disease

• NCT number: NCT01237860
• Study type: Interventional
• Source: Bioness Inc
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Completion date: January 2011