A Phase 3 interventional study of NESS L300 Plus System in Foot Drop, Thigh Muscles Weakness (Hamstrings or Quadriceps) and Upper Motor Neuron Injury or Disease, sponsored by Bioness Inc. Completed at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-11-16.
Sponsored by Bioness Inc · Phase 3, Interventional, and Treatment
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.
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).
601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.
This study's planned enrollment of 45 is close to the median of 46 across 444 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Bioness Inc is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients will receive the device for daily use of six (6) weeks.
Also known as: NESS L300, L300, L300 Plus
Occurence of anticipated and unanticipated adverse events
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.
Time frame: Throughout the 6 weeks of the study
Subject feedback regarding the safety of using the device
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.
Time frame: Week 6
Temporal Gait Parameters of the 2 Minute Walk Test
This outcome measure includes the following: gait velocity, gait asymmetry, single limb support (percentage of the singe stance phase).
Time frame: Week 1 and Week 6
10 Meter Obstacle Course Walking Velocity
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.
Time frame: Week 1 and Week 6
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Bioness Inc