Evaluation of the Safety and Performance of the NESS L300 Plus System (L300Plus)
|ClinicalTrials.gov Identifier: NCT01237860|
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : November 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Foot Drop Thigh Muscles Weakness (Hamstrings or Quadriceps) Upper Motor Neuron Injury or Disease||Device: NESS L300 Plus System||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of the Safety and Performance of the NESS L300 Plus System|
|Study Start Date :||September 2010|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
Device: NESS L300 Plus System
- NESS L300
- L300 Plus
- Occurence of anticipated and unanticipated adverse events [ Time Frame: Throughout the 6 weeks of the study ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237860
|Reuth Medical Center|
|Principal Investigator:||Jean-Jacques Vatine, MD||Reuth Medical Center|