Evaluation of the Safety and Performance of the NESS L300 Plus System

Foot Drop Clinical Trial

— L300Plus  

Official title:

Evaluation of the Safety and Performance of the NESS L300 Plus System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237860
• Other study ID #: 001 Rev 04
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2010
• Last updated: November 14, 2011
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: Bioness Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Drop
• Muscle Weakness
• Paresis
• Thigh Muscles Weakness (Hamstrings or Quadriceps)
• Upper Motor Neuron Injury or Disease

Intervention

Device:
• NESS L300 Plus System
The patients will receive the device for daily use of six (6) weeks.

Locations

Country	Name	City	State
Israel	Reuth Medical Center	Tel-Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Bioness Inc	Bioness Neuromodulation

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Epub 2004 Nov 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Throughout the 6 weeks of the study	Yes
Primary	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.	Week 6	Yes
Secondary	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).	Week 1 and Week 6	No
Secondary	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.	Week 1 and Week 6	No