AzTrials
AzTrials

Foot DropPhase 3L300PlusNCT01237860

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

A Phase 3 study testing NESS L300 Plus System in people with Foot Drop and Thigh Muscles Weakness (Hamstrings or Quadriceps), run by Bioness Inc at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
NESS L300 Plus System
Type of treatment
Medical device
How many people
45 participants
Where
1 siteIsrael
Study dates
Sep 2010to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Reuth Medical Center

    Tel Aviv

Other trials in Israel

About this study

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.

Read the 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).

Being tested
NESS L300 Plus System
Keywords
Foot drop, Thigh muscle weakness, Upper Motor Neuron injury or disease
Medical subject headings
Peroneal Neuropathies, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NESS L300 Plus SystemDevice

    Also called NESS L300, L300, L300 Plus

    The patients will receive the device for daily use of six (6) weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Throughout the 6 weeks of the study

  2. 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.

    Measured: Week 6

Secondary outcomes (2)

  1. 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).

    Measured: Week 1 and Week 6

  2. 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.

    Measured: Week 1 and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01237860
Sponsor's protocol ID
001 Rev 04
Acronym
L300Plus
Status last verified
Nov 2011
First submitted
8 Nov 2010
Last updated
16 Nov 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 9341692

  • 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.

    PubMed 16731222

  • 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.

    PubMed 8831470

  • 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.

    PubMed 15569875

  • 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.

    PubMed 18158427

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NESS L300 Plus System in people with Foot Drop and Thigh Muscles Weakness (Hamstrings or Quadriceps), run by Bioness Inc at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of anticipated and unanticipated adverse events (time frame: Throughout the 6 weeks of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01237860, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in