Evaluation of the Safety and Performance of the NESS L300 Plus System (L300Plus)
Primary Purpose
Foot Drop, Thigh Muscles Weakness (Hamstrings or Quadriceps), Upper Motor Neuron Injury or Disease
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
NESS L300 Plus System
Sponsored by
About this trial
This is an interventional treatment trial for Foot Drop focused on measuring Foot drop, Thigh muscle weakness, Upper Motor Neuron injury or disease
Eligibility Criteria
Inclusion Criteria:
- Upper motor neuron lesion
- Thigh muscle weakness - hamstrings or quadriceps strength of less than 4/5 according to manual muscle testing
- Foot drop - toe drag during walking
- Lower limb spasticity - 0-4 according to the modified Ashworth scale
- Responsible mental state, able to follow multiple step directions
- Between 18 and 80 years old
- Available for participation in the study
- Able to understand and sign the informed consent form
- Able to walk independently or with an assistance device (e.g. cane, walker etc.) / spot guarding for at least 10 meters
- Sufficient response to electrical stimulation (visible muscle contractions in a seated or prone position of each designated muscle separately)
Exclusion Criteria:
- Subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant
- Cancerous lesion of lower limb, present or suspected
- Medical condition that prevents participation or would likely lead to inability to comply with the protocol [e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc]
- Severe cognitive impairment (MMSE<21)
- Severe neglect (Star cancellation test<30)
- Skin lesion at the site of the stimulation electrodes
- Change in bone-joint structures of the lower limb, such as contractures or deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation
- Pregnancy
- Diagnosis of major depression or psychotic disorder
- Participation in another investigation that may directly or indirectly affect the study results
- Unable to tolerate electrical stimulation
Sites / Locations
- Reuth Medical Center
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT01237860
First Posted
November 8, 2010
Last Updated
November 14, 2011
Sponsor
Bioness Inc
Collaborators
Bioness Neuromodulation
1. Study Identification
Unique Protocol Identification Number
NCT01237860
Brief Title
Evaluation of the Safety and Performance of the NESS L300 Plus System
Acronym
L300Plus
Official Title
Evaluation of the Safety and Performance of the NESS L300 Plus System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioness Inc
Collaborators
Bioness Neuromodulation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Drop, Thigh Muscles Weakness (Hamstrings or Quadriceps), Upper Motor Neuron Injury or Disease
Keywords
Foot drop, Thigh muscle weakness, Upper Motor Neuron injury or disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NESS L300 Plus System
Other Intervention Name(s)
NESS L300, L300, L300 Plus
Intervention Description
The patients will receive the device for daily use of six (6) weeks.
Primary Outcome Measure Information:
Title
Occurence of anticipated and unanticipated adverse events
Description
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
Title
Subject feedback regarding the safety of using the device
Description
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
Secondary Outcome Measure Information:
Title
Temporal Gait Parameters of the 2 Minute Walk Test
Description
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
Title
10 Meter Obstacle Course Walking Velocity
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Upper motor neuron lesion
Thigh muscle weakness - hamstrings or quadriceps strength of less than 4/5 according to manual muscle testing
Foot drop - toe drag during walking
Lower limb spasticity - 0-4 according to the modified Ashworth scale
Responsible mental state, able to follow multiple step directions
Between 18 and 80 years old
Available for participation in the study
Able to understand and sign the informed consent form
Able to walk independently or with an assistance device (e.g. cane, walker etc.) / spot guarding for at least 10 meters
Sufficient response to electrical stimulation (visible muscle contractions in a seated or prone position of each designated muscle separately)
Exclusion Criteria:
Subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant
Cancerous lesion of lower limb, present or suspected
Medical condition that prevents participation or would likely lead to inability to comply with the protocol [e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc]
Severe cognitive impairment (MMSE<21)
Severe neglect (Star cancellation test<30)
Skin lesion at the site of the stimulation electrodes
Change in bone-joint structures of the lower limb, such as contractures or deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation
Pregnancy
Diagnosis of major depression or psychotic disorder
Participation in another investigation that may directly or indirectly affect the study results
Unable to tolerate electrical stimulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Vatine, MD
Organizational Affiliation
Reuth Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reuth Medical Center
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
9341692
Citation
Bonita R, Solomon N, Broad JB. Prevalence of stroke and stroke-related disability. Estimates from the Auckland stroke studies. Stroke. 1997 Oct;28(10):1898-902. doi: 10.1161/01.str.28.10.1898.
Results Reference
background
PubMed Identifier
16731222
Citation
Robbins SM, Houghton PE, Woodbury MG, Brown JL. The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil. 2006 Jun;87(6):853-9. doi: 10.1016/j.apmr.2006.02.026.
Results Reference
background
PubMed Identifier
8831470
Citation
Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
Results Reference
background
PubMed Identifier
15569875
Citation
Yan T, Hui-Chan CW, Li LS. Functional electrical stimulation improves motor recovery of the lower extremity and walking ability of subjects with first acute stroke: a randomized placebo-controlled trial. Stroke. 2005 Jan;36(1):80-5. doi: 10.1161/01.STR.0000149623.24906.63. Epub 2004 Nov 29.
Results Reference
background
PubMed Identifier
18158427
Citation
Hausdorff JM, Ring H. Effects of a new radio frequency-controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis. Am J Phys Med Rehabil. 2008 Jan;87(1):4-13. doi: 10.1097/PHM.0b013e31815e6680.
Results Reference
background
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Evaluation of the Safety and Performance of the NESS L300 Plus System
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