Trials / Completed
CompletedNCT01237860
Evaluation of the Safety and Performance of the NESS L300 Plus System
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Bioness Inc · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NESS L300 Plus System | The patients will receive the device for daily use of six (6) weeks. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2010-11-10
- Last updated
- 2011-11-16
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT01237860. Inclusion in this directory is not an endorsement.