Evaluation of the Safety and Performance of the NESS L300 Plus System (L300Plus)
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.
Thigh Muscles Weakness (Hamstrings or Quadriceps)
Upper Motor Neuron Injury or Disease
Device: NESS L300 Plus System
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety and Performance of the NESS L300 Plus System|
- Occurence of anticipated and unanticipated adverse events [ Time Frame: Throughout the 6 weeks of the study ] [ Designated as safety issue: Yes ]The occurence of anticipated and unanticipated events will be documented at each scheduled evaluation. In addition, subjects will be instructed to report adverse events 24 hours per day during the study period.
- Subject feedback regarding the safety of using the device [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]Patient feedback regarding the safety of using the device as reported during the study sessions and the completion of a satisfaction questionnaire will also be used to assess the system's safety.
- Temporal Gait Parameters of the 2 Minute Walk Test [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]This outcome measure includes the following: gait velocity, gait asymmetry, single limb support (percentage of the singe stance phase).
- 10 Meter Obstacle Course Walking Velocity [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]To imitate daily life situations, average gait speed will be also determine by measuring the time to walk 10m over an obstacle course, using the protocol in the Emory Functional Ambulation Profile.
|Study Start Date:||September 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Device: NESS L300 Plus System
- NESS L300 Plus System
- NESS L300
- L300 Plus
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).